Medical Device Manufacturer · US , Walker , MI

Bio Spec, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1984

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bio Spec, Inc. Microbiology ✕

3 devices

1-3 of 3

Cleared Jan 24, 1986

Microbiology · 18d

Cleared Jan 21, 1986

BIO SPEC GRAMAFLUOR TEST KIT

Microbiology · 11d

Cleared Apr 25, 1984

BIO SPEC STREP-A-FLUOR TEST KIT

Microbiology · 16d