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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 K103788
Device Name PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
Applicant
HORIBA ABX SAS
Parc Euromedecine
Rue Du Caducee - Bp7290
Montpellier,  FR 34184
Applicant Contact CAROLINE FERRER
Correspondent
HORIBA ABX SAS
Parc Euromedecine
Rue Du Caducee - Bp7290
Montpellier,  FR 34184
Correspondent Contact CAROLINE FERRER
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Codes
CEM   CGZ   JGS   JJE  
Date Received12/27/2010
Decision Date 11/08/2011
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
Recalls CDRH Recalls
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