# Cooper Biomedical, Inc.

- Location (FDA's records): Malvern, PA
- FDA decisions: 19 (1983–1987): 19 510(k) clearances
- Product codes: JJE (2), CEK (1), CZW (1), DFF (1), GTP (1), KTN (1), LBR (1), DEB (1), DCF (1), JGJ (1), DIC (1), CKB (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K863868: Immuno-Plate IV Radial Immuno Test Kit/Alpha-1 Ant (Feb 13, 1987)
- K864512: Immuno-Plate IV Radial Immuno Test Kit/Human Hapto (Feb 13, 1987)
- K863301: Demand Total Protein (Sep 26, 1986)
- K861926: Worthington HDL Precipitating Reagent Set (Jun 27, 1986)
- K854130: Demand Ethyl Alcohol (Nov 5, 1985)
- K853949: Demand Acid Phosphatase Reagent (Oct 16, 1985)
- K852262: Assist Clinical Chemistry Analyzer (Jun 25, 1985)
- K851285: Radial Immunodiffusion Plates CSF Igg & CSF Albumi (Jun 17, 1985)

Source page: https://510kreport.com/company/cooper-biomedical