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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 K112995
Model 4000
Device Name GEM PREMIER 4000
Original Applicant
INSTRUMENTATION LABORATORY CO.
526 route 303
orangeburg,  NY  10962
Original Contact carl marble
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGA   CGZ   CHL   CIG   GHS  
GKF   GKR   GLK   GLY   JFP   JGS  
JJY   KHP   MQM  
Date Received10/07/2011
Decision Date 05/03/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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