FDA applicant

Janssen Biochimica

Piscataway, NJ1 decision1992–19920 recalls

FDA records 1 decision for Janssen Biochimica (Piscataway, NJ) in 1992: 1 510(k) clearance. All are in product code CGM (Method, Immunodiffusion, Immunoglobulins (G…). 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 Biochimica’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Janssen Biochimica since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Janssen Biochimica 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.

Janssen Pharmaceutica NV 2 Janssen Diagnostics 1 Janssen Research Foundation 1

Janssen Biochimica

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Janssen”