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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hexokinase, Glucose
510(k) Number K153644
Device Name ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
Applicant
Elitechgroup
Zone Industrielle
Sees,  FR 61500
Applicant Contact Valerie Gourdon
Correspondent
Elitechgroup
21720 23rd Dr. SE Suite 150
Bothell,  WA  98021
Correspondent Contact Terry Trimingham
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Codes
JIX   JJY  
Date Received12/21/2015
Decision Date 09/07/2016
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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