FDA applicant

3M Diagnostic Systems, Inc.

Santa Clara, CA4 decisions1991–19910 recalls

FDA records 4 decisions for 3M Diagnostic Systems, Inc. (Santa Clara, CA) in 1991: 4 510(k) clearances. Most are in product codes LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen…) and DHB (System, Test, Radioallergosorbent (Rast)…). 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 3M Diagnostic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for 3M Diagnostic Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 3M Diagnostic Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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3M Diagnostic Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?