Medical Device Manufacturer · US , Mchenry , IL

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

19 submissions · 19 cleared · Since 1983

19

Total

19

Cleared

0

Denied

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

11 devices

1-11 of 11

Cleared Feb 13, 1987

IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT

Immunology · 133d

Cleared Feb 13, 1987

IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO

Immunology · 92d

Cleared Jun 17, 1985

RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI

Immunology · 77d

Cleared Jun 11, 1985

RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGM

Immunology · 71d

Cleared Jun 05, 1985

RADIAL IMMUNODIFFUSION PLATES C3 & C4

Immunology · 65d

Cleared May 24, 1985

RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI

Immunology · 53d

Cleared May 24, 1985

RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN

Immunology · 53d

Cleared May 23, 1985

RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN

Immunology · 52d

Cleared Jul 11, 1984

LEAP LE TEST KIT

Immunology · 16d

Cleared Apr 05, 1984

LEAP MONO TEST KIT

Immunology · 41d

Cleared Dec 27, 1983

LEAP STREP TEST KIT

Immunology · 63d