510(k) Report

FDA applicant

Advanced Care Products

Raritan, NJ6 decisions1984–19950 recalls

FDA records 6 decisions for Advanced Care Products (Raritan, NJ) from 1984 to 1995: 6 510(k) clearances. Most are in product codes LCX (Kit, Test, Pregnancy, Hcg, Over The Counter) and CEP (Radioimmunoassay, Luteinizing Hormone). 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, clinical chemistry panel, where it files most

How often FDA has decided Advanced Care Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Care Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Advanced Care Products’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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