FDA applicant

First Medical, Inc.

Irvine, CA4 decisions1998–20010 recalls

FDA records 4 decisions for First Medical, Inc. (Irvine, CA) from 1998 to 2001: 4 510(k) clearances. Most are in product codes MMI (Immunoassay Method, Troponin Subunit) and JHX (Fluorometric Method, Cpk Or Isoenzymes). 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 First Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for First Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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First Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?