Medical Device Manufacturer · US , Roswell , GA

Osmetech, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2005

Recent clearances: OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044, OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Osmetech, Inc. Chemistry ✕

2 devices

1-2 of 2

Cleared Aug 04, 2006

OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044

Chemistry · 45d

Cleared Sep 29, 2005

OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200

Chemistry · 64d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 26, 2026