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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode measurement, blood-gases (pco2, po2) and blood ph
510(k) Number K133407
Device Name GEM PREMIER 4000
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD,  MA  01730
Applicant Contact CAROL MARBLE
Correspondent
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD,  MA  01730
Correspondent Contact CAROL MARBLE
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   CIG   GHS  
GKF   GKR   GLY   JFP   JGS   KHP  
MQM  
Date Received11/06/2013
Decision Date 01/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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