Medical Device Manufacturer · US , Medfield , MA

Bayer Diagnostics Corp. - FDA 510(k) Cleared Devices

32 submissions · 32 cleared · Since 2000

32

Total

32

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bayer Diagnostics Corp. Hematology ✕

5 devices

1-5 of 5

Cleared Oct 15, 2002

ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD

Hematology · 64d

Cleared Sep 24, 2002

ADVIA TESTPOINT CSF CONTROL

Hematology · 18d

Cleared Sep 11, 2002

ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD

Hematology · 55d

Cleared Jul 17, 2002

BAYER RAPIDPOINT 405 SYSTEM

Hematology · 142d

Cleared Sep 21, 2001

ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION

Hematology · 23d