Medical Device Manufacturer · US , New York , NY

Bayer Healthcare, LLC - FDA 510(k) Cleared Devices

46 submissions · 46 cleared · Since 2003

46

Total

46

Cleared

0

Denied

38 devices

26-38 of 38

Cleared Feb 13, 2004

BAYER SPECIFIC PROTEIN REFERENCE SERUM

Chemistry · 71d

Cleared Dec 23, 2003

CLINITEST HCG PREGNANCY TEST

Chemistry · 125d

Cleared Dec 19, 2003

BAYER CLINITEK STATUS ANALYZER

Chemistry · 178d

Cleared Dec 17, 2003

BAYER RAPIDLAB 1200 SYSTEM

Chemistry · 212d

Cleared Sep 09, 2003

BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

Chemistry · 25d

Cleared Aug 06, 2003

TOX AMMONIA CALIBRATOR

Chemistry · 68d

Cleared Jun 25, 2003

BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL

Chemistry · 29d

Cleared Jun 25, 2003

LIPOPROTEIN CALIBRATOR

Chemistry · 26d

Cleared Jun 23, 2003

ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

Chemistry · 83d

Cleared Apr 10, 2003

BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR

Chemistry · 28d

Cleared Apr 09, 2003

BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL

Chemistry · 27d

Cleared Jan 31, 2003

SETPOINT CHEMISTRY CALIBRATOR

Chemistry · 14d

Cleared Jan 24, 2003

ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3

Chemistry · 14d