Medical Device Manufacturer · US , Walkersville , MD

Biowhittaker Molecular Applications, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1992

Recent clearances: VARICELISA, MODIFICATION, BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER, WHITSOFT

View 10 510(k) Devices ↓

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biowhittaker Molecular Applications, Inc. Immunology ✕

4 devices

1-4 of 4

Cleared Aug 23, 1993

RHEUMELISA II HISTONE ANTIBODY TEST KIT

Immunology · 82d

Cleared Mar 26, 1993

RHEUMELISA II JO-1 ANTIBODY TEST KIT

Immunology · 42d

Cleared Mar 23, 1993

RHEUMELISA II SCL-70 ANTIBODY TEST KIT

Immunology · 70d

Cleared Mar 30, 1992

RF STAT IGM TEST KIT

Immunology · 40d