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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, Low Density, Lipoprotein
510(k) Number K091333
Device Name S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
Applicant
Alfa Wassermann, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Applicant Contact HYMAN KATZ
Correspondent
Alfa Wassermann, Inc.
4 Henderson Dr.
West Caldwell,  NJ  07006
Correspondent Contact HYMAN KATZ
Regulation Number862.1475
Classification Product Code
MRR  
Date Received05/06/2009
Decision Date 08/03/2009
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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