Medical Device Manufacturer · US , Walkersville , MD

Bio-Whittaker, Inc., A Cambrex Co. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1995

Recent clearances: RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE, TOXOSTAT, RUBELISA (RUBESTAT)

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bio-Whittaker, Inc., A Cambrex Co. Microbiology ✕

3 devices

1-3 of 3

Cleared Sep 17, 1997

RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE

Microbiology · 145d

Cleared May 14, 1996

Microbiology · 595d

Cleared Aug 15, 1995

RUBELISA (RUBESTAT)

Microbiology · 217d