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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 K183546
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
CHL   GKF   KHP  
Date Received12/20/2018
Decision Date 02/16/2019
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
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