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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K024031
Device Name THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
Applicant
Theratest Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Applicant Contact MARIUS TEODORESCU
Correspondent
Theratest Laboratories, Inc.
1111 N. Main St.
Lombard,  IL  60148
Correspondent Contact MARIUS TEODORESCU
Regulation Number866.5100
Classification Product Code
LJM  
Date Received12/06/2002
Decision Date 02/06/2003
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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