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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 K072143
Device Name S40 CLINICAL ANALYZER, S TEST ALB
Applicant
Alfa Wassermann Diagnostic Technologies, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Applicant Contact DAVID SLAVIN
Correspondent
Alfa Wassermann Diagnostic Technologies, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Correspondent Contact DAVID SLAVIN
Regulation Number862.1035
Classification Product Code
CIX  
Date Received08/02/2007
Decision Date 07/14/2008
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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