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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, Sodium
510(k) Number K082462
Device Name GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
Applicant
Diamond Diagnostics, Inc.
333 Fiske St.
Holliston,  MA  01746
Applicant Contact LIANN VOO
Correspondent
Diamond Diagnostics, Inc.
333 Fiske St.
Holliston,  MA  01746
Correspondent Contact LIANN VOO
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   JFP   JIH  
Date Received08/27/2008
Decision Date 02/06/2009
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
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