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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 K950716
Device Name THERATEST EL-ANA PROFILES TEST SYSTEM
Applicant
Theratest Laboratories, Inc.
2201 W. Campbell Park Dr.
Chicago,  IL  60612
Applicant Contact MARIUS TEODORESCU
Correspondent
Theratest Laboratories, Inc.
2201 W. Campbell Park Dr.
Chicago,  IL  60612
Correspondent Contact MARIUS TEODORESCU
Regulation Number866.5100
Classification Product Code
LJM  
Date Received01/31/1995
Decision Date 09/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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