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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Sm Antibody, Antigen And Control
510(k) Number K013263
Device Name FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
Applicant
Fred Hutchinson Cancer Research Center
7914 Via Callendo
Carlsbad,  CA  92009
Applicant Contact SHELBY J HALL
Correspondent
Fred Hutchinson Cancer Research Center
7914 Via Callendo
Carlsbad,  CA  92009
Correspondent Contact SHELBY J HALL
Regulation Number866.5100
Classification Product Code
LKP  
Date Received10/01/2001
Decision Date 07/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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