FDA applicant
Ampcor Diagnostics, Inc.
FDA records 1 decision for Ampcor Diagnostics, Inc. (Bridgeport, NJ) in 1998: 1 510(k) clearance. All are in product code GMP (Antisera, Control For Nontreponemal Tests). 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 Ampcor Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ampcor Diagnostics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ampcor Diagnostics, Inc.’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) ReportOther applicant names beginning “Ampcor”
FDA records each applicant name separately; these may or may not be the same firm.