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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 K113374
Device Name ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 HENDERSON DRIVE
WEST CALDWELL,  NJ  07006
Applicant Contact HYMAN KATZ
Correspondent
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 HENDERSON DRIVE
WEST CALDWELL,  NJ  07006
Correspondent Contact HYMAN KATZ
Regulation Number862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CEK   CEO   CJY  
Date Received11/16/2011
Decision Date 07/13/2012
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
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