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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 K051066
Device Name THERATEST EL-ANA PROFILES
Applicant
Theratest Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Applicant Contact MARIUS TEDORESCU
Correspondent
Theratest Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Correspondent Contact MARIUS TEDORESCU
Regulation Number866.5100
Classification Product Code
LKP  
Subsequent Product Codes
LJM   LKO   LLL   LRM   MQA  
Date Received04/26/2005
Decision Date 10/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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