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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 K833148
Device Name ENZYME ANA TEST SYSTEM
Applicant
Immuno Concepts, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Immuno Concepts, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5100
Classification Product Code
LJM  
Date Received09/15/1983
Decision Date 11/21/1983
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
Recalls CDRH Recalls
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