510(k) Report

FDA applicant

Ampcor, Inc.

Bridgeport, NJ15 decisions1988–19920 recalls

FDA records 15 decisions for Ampcor, Inc. (Bridgeport, NJ) from 1988 to 1992: 15 510(k) clearances. Most are in product codes KTN (System, Test, Infectious Mononucleosis) and DCK (C-Reactive Protein, Antigen, Antiserum, And…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Ampcor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ampcor, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ampcor, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ampcor, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Ampcor”

FDA records each applicant name separately; these may or may not be the same firm.