# Iris Diagnostics

- Location (FDA's records): Chatsworth, CA
- FDA decisions: 2 (2007–2010): 2 510(k) clearances
- Product codes: GKL (1), JJW (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sysmex America, Inc.: 1 (https://510kreport.com/company/sysmex-america)
- International Remote Imaging Systems: 1 (https://510kreport.com/company/international-remote-imaging-systems)

## Firms that cite its devices most
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)

## Its most-cited devices
- K091539: IQ 200 Urine Analizer Body Fluids Module (2010), cited by 1

## Recent decisions
- K091539: IQ 200 Urine Analizer Body Fluids Module (Aug 31, 2010)
- K072640: Irispec,CA/CB/CC (Dec 21, 2007)

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