# Unotech Diagnostics, Inc.

- Location (FDA's records): San Leandro, CA
- FDA decisions: 3 (1997–2003): 3 510(k) clearances
- Product codes: JHI (3)
- 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
- K032987: Accutest HCG-Combo Model,HCG-004, Accustrip HCG-Combo Model, HCG-005 (Nov 17, 2003)
- K981838: Accustrip HCG-Urine Model Number HCG-002 (Jun 25, 1998)
- K971886: Accutest HCG-Urine (Jun 11, 1997)

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