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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
Recalls CDRH Recalls
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