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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion-Specific, Chloride
510(k) Number K052027
Device Name OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
Applicant
Osmetech, Inc.
235 Hembree Park Dr.
Roswell,  GA  30076
Applicant Contact DANIEL MCMINN
Correspondent
Osmetech, Inc.
235 Hembree Park Dr.
Roswell,  GA  30076
Correspondent Contact DANIEL MCMINN
Regulation Number862.1170
Classification Product Code
CGZ  
Subsequent Product Codes
CEM   CHL   JFP   JGS   JJE  
Date Received07/27/2005
Decision Date 09/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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