# Bio Spec, Inc.

- Location (FDA's records): Concord, CA
- FDA decisions: 3 (1984–1986): 3 510(k) clearances
- Product codes: JTO (2), GTP (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
- K860041: Strep D Fluor (Jan 24, 1986)
- K860091: Bio Spec Gramafluor Test Kit (Jan 21, 1986)
- K841479: Bio Spec Strep-a-Fluor Test Kit (Apr 25, 1984)

Source page: https://510kreport.com/company/bio-spec