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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K113435
Device Name ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
Applicant
Alfa Wassermann
4 Henderson Dr.
West Caldwell,  NJ  07006
Applicant Contact HYMAN KATZ
Correspondent
Alfa Wassermann
4 Henderson Dr.
West Caldwell,  NJ  07006
Correspondent Contact HYMAN KATZ
Regulation Number862.1160
Classification Product Code
KHS  
Subsequent Product Codes
CIG   JGJ  
Date Received11/21/2011
Decision Date 07/02/2012
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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