Medical Device Manufacturer · US , Frederick , MD

Columbia Bioscience, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1996

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Columbia Bioscience, Inc. Microbiology ✕

7 devices

1-7 of 7

Cleared Sep 03, 1999

IS H. PYLORI IGG ELISA TEST SYSTEM

Microbiology · 203d

Cleared Sep 03, 1999

MUMPS IGG ELISA TEST SYSTEM

Microbiology · 143d

Cleared Dec 16, 1998

IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

Microbiology · 63d

Cleared Dec 16, 1998

IS BORRELIA BURGDORFERI IGM TEST SYSTEM

Microbiology · 63d

Cleared Nov 25, 1998

EBNA-1 IGM ELISA TEST SYSTEM

Microbiology · 142d

Cleared Nov 25, 1998

EA-D IGM ELISA TEST SYSTEM

Microbiology · 142d

Cleared Nov 25, 1998

VCA IGM ELISA TEST SYSTEM

Microbiology · 142d