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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 K935129
Device Name RELISA ENA ANTIBODY SCREENING TEST SYSTEM
Applicant
Immuno Concepts, Inc.
9779 Business Park Dr.
Suite D
Sacramento,  CA  95827
Applicant Contact ERIC S HOY, PH.D
Correspondent
Immuno Concepts, Inc.
9779 Business Park Dr.
Suite D
Sacramento,  CA  95827
Correspondent Contact ERIC S HOY, PH.D
Regulation Number866.5100
Classification Product Code
LLL  
Date Received10/28/1993
Decision Date 01/31/1994
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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