Medical Device Manufacturer · US , South San Francisco , CA

Bionike, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1997

Recent clearances: BIONIKE AQ BARBITURATE TEST, ADVANCED QUALITY PREGNANCY TEST

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bionike, Inc. Toxicology ✕

1 devices

1-1 of 1

Cleared Jun 28, 1999

BIONIKE AQ BARBITURATE TEST

Toxicology · 151d