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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 K123018
Device Name ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
Applicant
Alfa Wassermann Diagnostic Technologies, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Applicant Contact HYMAN KATZ PH.D.
Correspondent
Alfa Wassermann Diagnostic Technologies, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Correspondent Contact HYMAN KATZ PH.D.
Regulation Number862.1345
Classification Product Code
CFR  
Subsequent Product Codes
CEM   CGZ   JGS   JJE  
Date Received09/28/2012
Decision Date 04/23/2013
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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