Medical Device Manufacturer · US , Walkersville , MD

Whittaker Bioproducts, Inc. - FDA 510(k) Cleared Devices

30 submissions · 30 cleared · Since 1984

30

Total

30

Cleared

0

Denied

FDA 510(k) Regulatory Record - Whittaker Bioproducts, Inc. Microbiology ✕

26 devices

1-12 of 26

Cleared Jul 30, 1992

LEGIONELLA STAT IGG/IGM TEST KIT

Microbiology · 490d

Cleared Oct 21, 1991

LYME STAT M TEST KIT

Microbiology · 371d

Cleared Oct 16, 1991

FIAX LYME M TEST KIT

Microbiology · 351d

Cleared Sep 25, 1991

EBNA STAT TEST KIT

Microbiology · 174d

Cleared May 07, 1991

PYLORI STAT TEST KIT

Microbiology · 201d

Cleared May 07, 1991

PYLORI-G FIAX TEST KIT

Microbiology · 152d

Cleared Jun 27, 1990

FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B

Microbiology · 90d

Cleared Jan 16, 1990

FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE A

Microbiology · 252d

Cleared Oct 16, 1989

FIAX EB VCA-M TEST KIT

Microbiology · 74d

Cleared Aug 30, 1989

EB VCA STAT M TEST KIT

Microbiology · 71d

Cleared May 10, 1989

STAT TEST KIT FOR EB-VCA IGG ANTIBODY

Microbiology · 70d

Cleared Feb 16, 1989

MURINE MONOCLONAL ANTI-ADENOVIRUS IGG

Microbiology · 49d