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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K982622
Device Name EL-ANA PROFILES: EL-ENA/5
Applicant
Theratest Laboratories, Inc.
2201 W. Campbell Park Dr.
Chicago,  IL  60612 -3501
Applicant Contact MARIUS TEODORESCU
Correspondent
Theratest Laboratories, Inc.
2201 W. Campbell Park Dr.
Chicago,  IL  60612 -3501
Correspondent Contact MARIUS TEODORESCU
Regulation Number866.5100
Classification Product Code
LLL  
Date Received06/18/1998
Decision Date 08/13/1998
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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