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Bayer Corp.

FDA 510(k) & PMA Approved Devices — 96 products

Total Devices96
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K024062 ASCENSIA BREEZE BLOOD GLUCOSE METERCGA2003-03-03 View
510(k) K023944 BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTJHI2003-02-11 View
510(k) K024017 BAYER ADVIA CENTAUR HER-2/NEU ASSAYNCW2003-01-30 View
510(k) K024234 ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALNBW2003-01-23 View
510(k) K022288 COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMLTJ2002-12-17 View
510(k) K023584 ASCENSIA DEX 2 DIABETES CARE SYSTEMNBW2002-11-20 View
510(k) K020828 CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEMLTK2002-07-24 View
510(k) K021428 CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEMJFY2002-07-05 View
510(k) K020806 ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAYLOJ2002-03-27 View
510(k) K013568 CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMDHX2001-12-21 View
510(k) K012337 BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEMDCN2001-12-06 View
510(k) K011963 ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAYCFR2001-11-20 View
510(k) K013272 ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYKLS2001-10-25 View
510(k) K012777 ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYSJZO2001-10-22 View
510(k) K012340 BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)JMO2001-10-01 View
510(k) K012205 GLUCOMETER DEX TEST SENSORNBW2001-09-12 View
510(k) K010755 BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAYLGD2001-08-20 View
510(k) K010668 BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAYLFX2001-07-05 View
510(k) K003412 ADVIA CENTAUR RUBELLA IGG ASSAYLFX2001-04-13 View
510(k) K010201 BAYER ADVIA IMS SYSTEMMMI2001-03-29 View
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