Medical Device Manufacturer · US , Blairstown , NJ

Clark Laboratories, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1992

Recent clearances: VCA IGM ELISA TEST SYSTEM, VCA IGG ELISA TEST SYSTEM, EBNA-1 IGM ELISA TEST SYSTEM

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Clark Laboratories, Inc. Immunology ✕

9 devices

1-9 of 9

Cleared Sep 08, 1993

ENCORE ENA COMBINED EIA

Immunology · 163d

Cleared Jan 26, 1993

ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA

Immunology · 71d

Cleared Dec 23, 1992

Immunology · 160d

Cleared Dec 01, 1992

Immunology · 243d

Cleared Dec 01, 1992

Immunology · 225d

Cleared Oct 16, 1992

Immunology · 150d

Cleared Oct 13, 1992

Immunology · 159d

Cleared Sep 25, 1992

ENCORE RHEUMATOID FACTOR EIA

Immunology · 44d

Cleared Mar 18, 1992

Immunology · 65d