# Epitope Diagnostics, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 1 (2005–2005): 1 510(k) clearance
- Product codes: KHE (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
- K051806: Care Fecal Occult Blood Test, Model KT313 (Oct 3, 2005)

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