# Osmetech Molecular Diagnostics

- Location (FDA's records): Pasadena, CA
- FDA decisions: 3 (2008–2010): 3 510(k) clearances
- Product codes: NUA (1), ODW (1), NPQ (1)
- Predicates its devices cite: 7 (3 its own); citations of its devices by later devices: 6 (3 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
- Clinical Micro Sensors, Inc.: 2 (https://510kreport.com/company/clinical-micro-sensors)
- Third Wave Technologies, Inc.: 1 (https://510kreport.com/company/third-wave-technologies)
- Nanosphere, Inc.: 1 (https://510kreport.com/company/nanosphere)

## Firms that cite its devices most
- Akonni Biosystems, Inc.: 1 (https://510kreport.com/company/akonni-biosystems)
- Genmark Diagnostics, Incorporated: 1 (https://510kreport.com/company/genmark-diagnostics)
- Clinical Micro Sensors, Inc.: 1 (https://510kreport.com/company/clinical-micro-sensors)

## Its most-cited devices
- K073720: Esensor Warfarin Sensitivity and XT-8 Instrument (2008), cited by 5
- K090901: Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8 (2009), cited by 1

## Recent decisions
- K093974: Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii Genotyping (Apr 22, 2010)
- K090901: Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8 (Jul 6, 2009)
- K073720: Esensor Warfarin Sensitivity and XT-8 Instrument (Jul 17, 2008)

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