Medical Device Manufacturer · US , Mchenry , IL

Cooper Biomedical, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1983

Recent clearances: IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT, IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO, DEMAND TOTAL PROTEIN

19

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cooper Biomedical, Inc. Chemistry ✕

8 devices

1-8 of 8

Cleared Sep 26, 1986

DEMAND TOTAL PROTEIN

Chemistry · 32d

Cleared Jun 27, 1986

WORTHINGTON HDL PRECIPITATING REAGENT SET

Chemistry · 39d

Cleared Nov 05, 1985

DEMAND ETHYL ALCOHOL

Chemistry · 27d

Cleared Oct 16, 1985

DEMAND ACID PHOSPHATASE REAGENT

Chemistry · 22d

Cleared Jun 25, 1985

ASSIST CLINICAL CHEMISTRY ANALYZER

Chemistry · 32d

Cleared May 10, 1985

DEMAND MAGNESIUM

Chemistry · 17d

Cleared Jun 07, 1984

Chemistry · 43d

Cleared May 07, 1984

ION SELECTIVE ELECTRODE

Chemistry · 56d