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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, Indirect Immunofluorescent, Antigen, Control
510(k) Number K803276
Device Name ANA-IFA 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
DHN  
Date Received12/29/1980
Decision Date 01/26/1981
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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