FDA applicant

Microdiagnostics, Inc.

Laguna Niguel, CA10 decisions1991–20010 recalls

FDA records 10 decisions for Microdiagnostics, Inc. (Laguna Niguel, CA) from 1991 to 2001: 10 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and DIO (Enzyme Immunoassay, Cocaine And Cocaine…). 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 toxicology panel, where it files most

How often FDA has decided Microdiagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Microdiagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Microdiagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?