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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K131488
Device Name ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
Applicant
Alfa Wassermann Diagnostics Technologies, LLC
4 Henderson Dr.
West Caldwell,  NJ  07006
Applicant Contact HYMAN KATZ
Correspondent
Alfa Wassermann Diagnostics Technologies, LLC
4 Henderson Dr.
West Caldwell,  NJ  07006
Correspondent Contact HYMAN KATZ
Regulation Number862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CEK   CJY  
Date Received05/23/2013
Decision Date 08/19/2013
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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