# SEKISUI Diagnostics, LLC

- Location (FDA's records): San Diego, CA
- FDA decisions: 6 (2012–2025): 6 510(k) clearances
- Product codes: PSZ (3), KTN (1), GNX (1), KHE (1)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wyntek Diagnostics, Inc.: 1 (https://510kreport.com/company/wyntek-diagnostics)
- Genzyme Corp.: 1 (https://510kreport.com/company/genzyme)
- Alfa Scientific Designs, Inc.: 1 (https://510kreport.com/company/alfa-scientific-designs)
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)

## Its most-cited devices
- K182001: Acucy Influenza A&B Test with the Acucy System (2018), cited by 1

## Recent decisions
- K241188: Acucy® Influenza A&B Test with the Acucy® 2 System (Apr 18, 2025)
- K192719: Osom Ultra Plus Flu A&B Test Kit (Apr 3, 2020)
- K182001: Acucy Influenza A&B Test with the Acucy System (Dec 17, 2018)
- K181436: OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test (Jun 22, 2018)
- K121397: Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test Kit (Dec 28, 2012)
- K123182: Osom Influenza a&B Test Model 190 (Nov 5, 2012)

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