FDA applicant

Horizon Diagnostics, Inc.

Ann Arbor, MI7 decisions1993–19970 recalls

FDA records 7 decisions for Horizon Diagnostics, Inc. (Ann Arbor, MI) from 1993 to 1997: 7 510(k) clearances. Most are in product codes CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes) and CIG (Diazo Colorimetry, Bilirubin). 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 Horizon Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Horizon Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Horizon”

FDA records each applicant name separately; these may or may not be the same firm.

Horizon Medical Products, Inc. 16 Horizon Medical, Inc. 3 Horizon Chemical Co. 1 Horizon Surgical, Inc. 1

Horizon Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Horizon”