# Elitechgroup

- Location (FDA's records): Bothell, WA
- FDA decisions: 18 (2011–2018): 18 510(k) clearances
- Names in FDA's records: Elitechgroup (17); Elitechgroup, Inc. (1)
- Product codes: JIX (3), JHW (2), CIG (2), CFR (1), KHS (1), CJY (1), KTB (1), JIT (1), JFJ (1), PGI (1), CJE (1), JFY (1)
- Predicates its devices cite: 36 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 21 (https://510kreport.com/company/roche-diagnostics)
- Horiba Abx: 4 (https://510kreport.com/company/horiba-abx)
- Rochdiag: 3 (https://510kreport.com/company/rochdiag)
- Bio-Rad Laboratories, Inc.: 3 (https://510kreport.com/company/bio-rad-laboratories)
- Roche Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/roche-diagnostic-systems)
- Wescor, Inc.: 1 (https://510kreport.com/company/wescor)
- Luminex Corporation: 1 (https://510kreport.com/company/luminex)
- Pointe Scientific, Inc.,: 1 (https://510kreport.com/company/pointe-scientific)

## Its most-cited devices
- K122083: Elitech Clinical Systems CK Nac SL (2012), cited by 1

## Recent decisions
- K180559: HSV 1 & 2 ELITe MGB Kit; ELITe InGenius (Oct 29, 2018)
- K180627: Macroduct Advanced Model 3710 (Jul 27, 2018)
- K171401: ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 (Jul 11, 2017)
- K153644: ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II (Sep 7, 2016)
- K151113: ELITech Clinical Systems CALCIUM ARSENAZO (Jul 22, 2015)
- K151552: ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II (Jul 8, 2015)
- K141265: Elitech Clinical Systems Envoy 500 CK Reagent Kit (Jul 18, 2014)
- K132399: Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine Control BI-Level (Jan 3, 2014)

Source page: https://510kreport.com/company/elitechgroup