# Bionike, Inc.

- Location (FDA's records): Simi Valley, CA
- FDA decisions: 2 (1997–1999): 2 510(k) clearances
- Product codes: DIS (1), LCX (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
- K990280: Bionike AQ Barbiturate Test (Jun 28, 1999)
- K970008: Advanced Quality Pregnancy Test (Feb 18, 1997)

Source page: https://510kreport.com/company/bionike