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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
Model SA2001 SA1022 SA1009 SA1016
Device Name ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT
Original Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 henderson drive
west caldwell,  NJ  07006
Original 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 - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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