510(k) Report

FDA applicant

Janssen Research Foundation

Piscataway, NJ1 decision1991–19910 recalls

FDA records 1 decision for Janssen Research Foundation (Piscataway, NJ) in 1991: 1 510(k) clearance. All are in product code DEW (Igg, Antigen, Antiserum, Control). 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 Janssen Research Foundation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Janssen Research Foundation since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Janssen”

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