Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Diagnostic Specialties

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K971458 ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITJIQ1997-09-02 View
510(k) K941001 ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITGIS1994-08-30 View
510(k) K930823 PROTEIN-BOUND GLUCOSE ASSAYN KITLCP1993-08-19 View
510(k) K922032 ENZIP URINARY MICROALBUMIN TESTJIR1992-07-30 View
510(k) K831180 PREGNA-CERT, SLIDE PREGNANCY TESTJHJ1983-05-27 View
510(k) K823109 GENERIC PREGNANCY TESTLCX1982-11-10 View
510(k) K813608 POTASSIUM REAGENT SETCEJ1982-01-22 View
510(k) K813412 GLUCOSE ENZYME-COLOR REAGENT SETCGA1981-12-31 View
↑