FDA applicant

Em Diagnostic Systems, Inc.

Gibbstown, NJ288 decisions1984–19940 recalls

FDA records 288 decisions for Em Diagnostic Systems, Inc. (Gibbstown, NJ) from 1984 to 1994: 288 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and CGS (Nad Reduction/Nadh Oxidation, 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 Em Diagnostic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Em Diagnostic Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Em Diagnostic Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?