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idK153137_s0_e2000 | K153137.txt | purpose for submission | Clearance of a new device | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Es... |
idK153137_s0_e2000 | K153137.txt | measurand | Anti-PF4/Heparin Total Antibodies | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Es... |
idK153137_s0_e2000 | K153137.txt | type of test | Automated, latex enhanced immuno-turbidimetric assay | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary an... |
idK153137_s0_e2000 | K153137.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary a... |
idK153137_s0_e2000 | K153137.txt | panel | Hematology (81) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary ... |
idK153137_s0_e2000 | K153137.txt | predicate device name | Asserachrom HPIA Test kit from Diagnostica Stago | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Es... |
idK153137_s0_e2000 | K153137.txt | applicant | Instrumentation Laboratory (IL) Co. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary a... |
idK153137_s8000_e10000 | K153137.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK153137_s8000_e10000 | K153137.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK150041_s0_e2000 | K150041.txt | purpose for submission | Clearance of a new device | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietar... |
idK150041_s0_e2000 | K150041.txt | measurand | Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietar... |
idK150041_s0_e2000 | K150041.txt | type of test | Whole blood hemostasis | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Propri... |
idK150041_s0_e2000 | K150041.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Propr... |
idK150041_s0_e2000 | K150041.txt | panel | Hematology (81) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Prop... |
idK150041_s0_e2000 | K150041.txt | predicate device name | Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietar... |
idK150041_s0_e2000 | K150041.txt | applicant | Coramed Technologies, LLC | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Propr... |
idK150041_s8000_e10000 | K150041.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK150041_s8000_e10000 | K150041.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK143329_s0_e2000 | K143329.txt | purpose for submission | To obtain clearance for a new device, Amplivue® Trichomonas Assay | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-depend... |
idK143329_s0_e2000 | K143329.txt | measurand | A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-depend... |
idK143329_s0_e2000 | K143329.txt | type of test | Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-de... |
idK143329_s0_e2000 | K143329.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-d... |
idK143329_s0_e2000 | K143329.txt | product code | OUY - Trichomonas vaginalis nucleic acid amplification test system | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-d... |
idK143329_s0_e2000 | K143329.txt | panel | 83 - Microbiology | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-... |
idK143329_s0_e2000 | K143329.txt | intended use | The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females... | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-de... |
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