FDA applicant
Atlantic Antibodies
FDA records 18 decisions for Atlantic Antibodies (Scarborough, ME) from 1983 to 1989: 18 510(k) clearances. Most are in product codes MSJ (Apolipoproteins) and CZP (Iga, Antigen, Antiserum, Control). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Atlantic Antibodies’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Atlantic Antibodies since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Atlantic Antibodies’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report