FDA applicant

Hoffmann-La Roche, Inc.

Mchenry, IL49 decisions1976–19850 recalls

FDA records 49 decisions for Hoffmann-La Roche, Inc. (Mchenry, IL) from 1976 to 1985: 49 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and DJP (Radioimmunoassay, Amphetamine). 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 Hoffmann-La Roche, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hoffmann-La Roche, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Hoffmann-La Roche, Inc.

Which product codes does it file in?

What has FDA decided for it lately?