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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cooper Biomedical, Inc. — Predicate Candidate Screening

19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

52 daysmedian FDA review time
92 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K864512IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTOCooper Biomedical, Inc.1987-02-13920
K863868IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANTCooper Biomedical, Inc.1987-02-131330
K863301DEMAND TOTAL PROTEINCooper Biomedical, Inc.1986-09-26320
K861926WORTHINGTON HDL PRECIPITATING REAGENT SETCooper Biomedical, Inc.1986-06-27390
K854130DEMAND ETHYL ALCOHOLCooper Biomedical, Inc.1985-11-05270
K853949DEMAND ACID PHOSPHATASE REAGENTCooper Biomedical, Inc.1985-10-16220
K852262ASSIST CLINICAL CHEMISTRY ANALYZERCooper Biomedical, Inc.1985-06-25320
K851285RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMICooper Biomedical, Inc.1985-06-17770
K851284RADIAL IMMUNO-DIFFUSION PLATES IGA, IGD, IGG & IGMCooper Biomedical, Inc.1985-06-11710
K851286RADIAL IMMUNODIFFUSION PLATES C3 & C4Cooper Biomedical, Inc.1985-06-05650
K851282RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULICooper Biomedical, Inc.1985-05-24530
K851287RADIAL IMMUNODIFFUSION PLATES TRANSFERRINCooper Biomedical, Inc.1985-05-24530
K851283RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMINCooper Biomedical, Inc.1985-05-23520
K851657DEMAND MAGNESIUMCooper Biomedical, Inc.1985-05-10170
K842484LEAP LE TEST KITCooper Biomedical, Inc.1984-07-11160
K841726DEMAND C02Cooper Biomedical, Inc.1984-06-07430
K841076ION SELECTIVE ELECTRODECooper Biomedical, Inc.1984-05-07560
K840822LEAP MONO TEST KITCooper Biomedical, Inc.1984-04-05410
K833738LEAP STREP TEST KITCooper Biomedical, Inc.1983-12-27630

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda