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Cooper Biomedical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K863868IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANTFebruary 13, 1987
K864512IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTOFebruary 13, 1987
K863301DEMAND TOTAL PROTEINSeptember 26, 1986
K861926WORTHINGTON HDL PRECIPITATING REAGENT SETJune 27, 1986
K854130DEMAND ETHYL ALCOHOLNovember 5, 1985
K853949DEMAND ACID PHOSPHATASE REAGENTOctober 16, 1985
K852262ASSIST CLINICAL CHEMISTRY ANALYZERJune 25, 1985
K851285RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMIJune 17, 1985
K851284RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGMJune 11, 1985
K851286RADIAL IMMUNODIFFUSION PLATES C3 & C4June 5, 1985
K851282RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULIMay 24, 1985
K851287RADIAL IMMUNODIFFUSION PLATES TRANSFERRINMay 24, 1985
K851283RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMINMay 23, 1985
K851657DEMAND MAGNESIUMMay 10, 1985
K842484LEAP LE TEST KITJuly 11, 1984
K841726DEMAND C02June 7, 1984
K841076ION SELECTIVE ELECTRODEMay 7, 1984
K840822LEAP MONO TEST KITApril 5, 1984
K833738LEAP STREP TEST KITDecember 27, 1983