# Genus Diagnostics

- Location (FDA's records): Woburn, MA
- FDA decisions: 9 (1985–1986): 9 510(k) clearances
- Product codes: KIR (8), GQN (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
- K854974: HSV Idr (Mar 7, 1986)
- K852206: Hep-2 Gencells (Jun 4, 1985)
- K852205: RMK Gencells Culture System (Jun 4, 1985)
- K852204: Mccoy Gencells (Jun 4, 1985)
- K851927: Vero Gencells (May 20, 1985)
- K851928: Hek Gencells (May 20, 1985)
- K851561: WI-38 Gencells (May 10, 1985)
- K851562: MRC-5 Gencells (May 10, 1985)

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