FDA applicant
American Bioproducts Co.
FDA records 79 decisions for American Bioproducts Co. (Parsippany, NJ) from 1985 to 1998: 79 510(k) clearances. Most are in product codes GGP (Test, Qualitative And Quantitative Factor…) and GJT (Plasma, Coagulation Factor Deficient). Its devices cite 5 predicates, 4 of them its own earlier devices. 22 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided American Bioproducts Co.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Bioproducts Co. since 2007.
Recalls per year
1in 2026
Class I Class II/III not classified
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