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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K080073
Device Name S-TEST CREATININE (CRE)
Applicant
Alfa Wassermann, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Applicant Contact DAVID SLAVIN
Correspondent
Alfa Wassermann, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Correspondent Contact DAVID SLAVIN
Regulation Number862.1225
Classification Product Code
JFY  
Date Received01/11/2008
Decision Date 06/30/2008
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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