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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K072142
Device Name S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
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 Number862.1050
Classification Product Code
CKF  
Subsequent Product Codes
CIJ   CIT  
Date Received08/02/2007
Decision Date 06/26/2008
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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