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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, C-Reactive Protein
510(k) Number K083040
Device Name S-TEST C-REACTIVE PROTEIN (CRP)
Applicant
Alfa Wassermann Diagnostic Technologies, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Applicant Contact DENNIS TASCHEK
Correspondent
Alfa Wassermann Diagnostic Technologies, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Correspondent Contact DENNIS TASCHEK
Regulation Number866.5270
Classification Product Code
DCN  
Date Received10/14/2008
Decision Date 01/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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