FDA applicant
New Horizons Diagnostics Co.
FDA records 10 decisions for New Horizons Diagnostics Co. (Columbia, MD) from 1982 to 1995: 10 510(k) clearances. Most are in product codes LIC (Antiserum, Coagglutination (Direct) Neisseria…) and GTZ (Antisera, All Groups, Streptococcus Spp.). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided New Horizons Diagnostics Co.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for New Horizons Diagnostics Co. since 2007.
Recalls per year
No recall linked to its devices since 2007.
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