# Bionike Laboratories, Inc.

- Location (FDA's records): South San Francisco, CA
- FDA decisions: 6 (1995–1999): 6 510(k) clearances
- Product codes: JHI (2), LDJ (1), DJG (1), LCM (1), DIO (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
- K993945: Bionike AQ Phencyclidine (PCP) Test (Dec 7, 1999)
- K972384: AQ One Step Cocaine Test (Aug 6, 1997)
- K971841: Bionike AQ One Step Cannabinoids (THC) Test (Jun 25, 1997)
- K971361: AQ Opiates (Morphine) Test (Jun 6, 1997)
- K960992: Bionike a/Q Pregnancy Test (Apr 25, 1996)
- K954901: Bionike a/Q Pregnancy Test (Dec 11, 1995)

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