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Ortho Clinical Diagnostics

FDA 510(k) & PMA Approved Devices — 36 products

Total Devices36
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K241534 VITROS Immunodiagnostic Products Syphilis Reagent PackLIP2024-08-28 View
510(k) K233581 VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA2024-05-08 View
510(k) K221197 VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW2023-09-05 View
510(k) K231517 VITROS Immunodiagnostic Products CEA Reagent PackDHX2023-08-23 View
510(k) K231525 VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG2023-08-09 View
510(k) K221355 VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK2022-12-12 View
510(k) K213626 VITROS AFPLOJ2022-06-15 View
510(k) K212648 VITROS Immunodiagnostic Products CK-MB Reagent PackJHX2022-01-28 View
510(k) K201312 VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC2021-10-04 View
510(k) K200236 VITROS BRAHMS PCT Reagent Pack and CalibratorsPMT2020-02-25 View
510(k) K163433 VITROS Chemistry Products GLU SlidesCGA2017-09-18 View
510(k) K160712 VITROS Chemistry Products hsCRP ReagentDCK2017-07-14 View
510(k) K171168 VITROS Immunodiagnostic Products Insulin CalibratorsJIT2017-05-16 View
510(k) K162020 VITROS Chemistry Products Cl- SlidesCGZ2016-12-16 View
510(k) K101921 VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VITCEW2010-10-22 View
510(k) K083173 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEMJLW2008-12-22 View
510(k) K063720 VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERSDHA2007-04-09 View
510(k) K062165 VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSDIS2007-01-05 View
510(k) K062838 VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303MMI2006-12-19 View
510(k) K060480 VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLSCGR2006-07-03 View
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