# Allelix Diagnostics, Inc.

- Location (FDA's records): Canada L4v 1p1, CA
- FDA decisions: 2 (1988–1989): 2 510(k) clearances
- Product codes: GTZ (1), GMP (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
- K885298: Visuwell Reagin Test 960 Test Kit (Mar 15, 1989)
- K880665: Modified Group a Streptococcus Detection Kit (Mar 1, 1988)

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