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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 K203790
Device Name GEM Premier 5000
Applicant
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford,  MA  01730
Applicant Contact Gabriella Erdosy
Correspondent
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford,  MA  01730
Correspondent Contact Gabriella Erdosy
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GHS   GKF  
GKR   GLY   JFP   JGS   KHP   MQM  
Date Received12/28/2020
Decision Date 08/20/2021
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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