FDA applicant

Wampole Laboratories

Cranbury, NJ12 decisions1976–19970 recalls

FDA records 12 decisions for Wampole Laboratories (Cranbury, NJ) from 1976 to 1997: 12 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and LSR (Reagent, Borrelia Serological Reagent). 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 Wampole Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wampole Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Wampole Laboratories

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?