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Johnson & Johnson Clinical Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 33 products

Total Devices33
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K980283 VITROS CHEMISTRY PRODUCTS CRBM SLIDESKLT1998-02-25 View
510(k) K974644 VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJX1998-01-13 View
510(k) K973517 VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERSJJY1997-09-25 View
510(k) K973030 VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)JJY1997-09-04 View
510(k) K972133 VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)JLS1997-06-24 View
510(k) K970894 VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)DHA1997-04-14 View
510(k) K965142 VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)CEC1997-03-18 View
510(k) K970643 VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)CHP1997-03-18 View
510(k) K970281 VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSCFT1997-02-25 View
510(k) K964982 VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)CEP1997-02-20 View
510(k) K964960 VITROS CHEMISTRY PRODUCTS UPRO SLIDESJGP1997-02-18 View
510(k) K964720 VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)CGJ1997-02-04 View
510(k) K970016 VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)CDP1997-01-30 View
510(k) K965048 VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)JJY1997-01-27 View
510(k) K964721 VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)KLI1996-12-18 View
510(k) K964558 VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)JLW1996-12-16 View
510(k) K964310 VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)CDP1996-11-27 View
510(k) K964308 VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)KHQ1996-11-27 View
510(k) K962919 VITROS IMMUNODIAGNOSTIC SYSTEMKHO1996-10-18 View
510(k) K962235 VITROS SPECIALTY DILUENTJJE1996-06-26 View
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