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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 K153692
Device Name Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
Applicant
Infrared Laboratory Systems, LLC (Dba Synermed)
17408 Tiller Ct. Suite 1900
Westfield,  IN  40674
Applicant Contact JULIE PASCHAL
Correspondent
Infrared Laboratory Systems, LLC (Dba Synermed)
17408 Tiller Ct. Suite 1900
Westfield,  IN  40674
Correspondent Contact JULIE PASCHAL
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
JJE  
Date Received12/23/2015
Decision Date 06/24/2016
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
Predetermined Change
Control Plan Authorized		 No
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