Medical Device Manufacturer · US , St.Louis , MO

Bioclinical Systems, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1985

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bioclinical Systems, Inc. Chemistry ✕

7 devices

1-7 of 7

Cleared Apr 21, 1986

MICRO-ELISA HLH TEST KIT MONOCLONAL

Chemistry · 82d

Cleared Apr 21, 1986

VISI-CHECK HLH TEST MONOCLONAL

Chemistry · 82d

Cleared Jan 13, 1986

MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO

Chemistry · 102d

Cleared Jan 07, 1986

MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT

Chemistry · 69d

Cleared Mar 05, 1985

NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG

Chemistry · 54d

Cleared Mar 05, 1985

BCS GLUCOSE COLORIMETRIC TEST

Chemistry · 42d

Cleared Feb 07, 1985

BCS POTASSIUM TURBIDIMETRIC TEST

Chemistry · 16d