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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 K955481
Device Name THERATEST KIT (MODIFICATION)
Applicant
Theratest Laboratories, Inc.
2201 W. Campbell Park Dr.
Chicago,  IL  60612
Applicant Contact CHRISTOPHER J FROELICH
Correspondent
Theratest Laboratories, Inc.
2201 W. Campbell Park Dr.
Chicago,  IL  60612
Correspondent Contact CHRISTOPHER J FROELICH
Regulation Number866.5100
Classification Product Code
LJM  
Date Received11/15/1995
Decision Date 03/06/1996
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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