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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name glucose oxidase, glucose
510(k) Number K223090
Device Name GEM Premier ChemSTAT
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 Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
CDQ   CEM   CGZ   CHL   GKF  
JFP   JFY   JGS   KHP   KHS  
Date Received09/30/2022
Decision Date 01/27/2023
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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