Medical Device Manufacturer · US , Roswell , GA

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

2 submissions · 2 cleared · Since 2005

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 . 175,972 total devices indexed.

Last updated: Apr 28, 2026