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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, Potassium
510(k) Number K061730
Device Name OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
Applicant
Osmetech, Inc.
235 Hembree Park Dr.
Roswell,  GA  30076
Applicant Contact BERNIE HEITZ
Correspondent
Osmetech, Inc.
235 Hembree Park Dr.
Roswell,  GA  30076
Correspondent Contact BERNIE HEITZ
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CHL   GKR   GLY   JFP   JGS  
JJY  
Date Received06/20/2006
Decision Date 08/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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