# Horizon Diagnostics, Inc.

- Location (FDA's records): Ann Arbor, MI
- FDA decisions: 7 (1993–1997): 7 510(k) clearances
- Product codes: CGS (1), CIG (1), CDQ (1), CDT (1), JFJ (1), JIY (1), JGJ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K971566: Creatine Kinase-MB Reagent Set (Jul 14, 1997)
- K933722: Horizon Diagnostics Triglycerides-Gpo Reagent (Jun 13, 1996)
- K935712: Iron/Tibc Reagent (Sep 20, 1995)
- K930678: Amylase (Apr 6, 1994)
- K934533: Bun-300/Bun-500 Urea Nitrogen Reagent (Nov 26, 1993)
- K930679: Direct Bilirubin (Jun 29, 1993)
- K930074: IN-Vitro Diagnostic Reagent Set (May 11, 1993)

Source page: https://510kreport.com/company/horizon-diagnostics