££......Osmetech ......Smell the Success.....££

510(k) Premarket Notification Database
Device Classification Name electrode, ion-specific, chloride
510(k) Number K052027
Regulation Number 862.1170
Device Name OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
Applicant OSMETECH, INC.
235 hembree park drive
roswell, GA 30076

Contact daniel mcminn
Classification Product Code CGZ

Subsequent Product Codes CEM CHL JFP JGS JJE

Date Received 08/02/2005
Decision Date 09/29/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Statement/Summary/Purged Status Summary only
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No


PC

Edit: Happy New Year to all.