# Osmetech, Inc.

- Location (FDA's records): Roswell, GA
- FDA decisions: 4 (2001–2006): 4 510(k) clearances
- Names in FDA's records: Osmetech, Inc. (2); Osmetech (2)
- Product codes: CGZ (1), LIB (1), CEM (1), JXA (1)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Avl Scientific Corp.: 7 (https://510kreport.com/company/avl-scientific)
- Roche Diagnostic Systems, Inc.: 2 (https://510kreport.com/company/roche-diagnostic-systems)

## Its most-cited devices
- K011043: Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti) (2001), cited by 1

## Recent decisions
- K061730: Osmetech Opti R Critical Care Analyzer, Model GD7044 (Aug 4, 2006)
- K052027: Opti Lion Electrolyte Analyzer, Model GD7200 (Sep 29, 2005)
- K023677: Osmetech Microbial Analyser-Bacterial Vaginosis (Oma-BV) (Jan 29, 2003)
- K011043: Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti) (Nov 30, 2001)

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