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. Immunology ✕

4 devices

1-4 of 4

Cleared Feb 02, 1999

IS ANTI-TPO IGG ELISA TEST SYSTEM

Immunology · 69d

Cleared Dec 07, 1998

ANTI-TG IGG ELISA TEST SYSTEM

Immunology · 59d

Cleared Nov 18, 1998

IS-ANTI-MPO IGG ELISA TEST SYSTEM

Immunology · 54d

Cleared Nov 18, 1998

IS-ANTI-PR3 IGG ELISA TEST SYSTEM

Immunology · 27d