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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferrozine (Colorimetric) Iron Binding Capacity
510(k) Number K113438
Device Name ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
Applicant
Alfa Wassermann Diagnostic Technologies, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Applicant Contact HYMAN KATZ
Correspondent
Alfa Wassermann Diagnostic Technologies, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Correspondent Contact HYMAN KATZ
Regulation Number862.1415
Classification Product Code
JMO  
Subsequent Product Codes
CHI   JIY  
Date Received11/21/2011
Decision Date 06/01/2012
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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