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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 K955603
Device Name RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM
Applicant
Immuno Concepts, Inc.
9779 Business Park Dr.
Suite D
Sacramento,  CA  95827
Applicant Contact ERIC S HOY
Correspondent
Immuno Concepts, Inc.
9779 Business Park Dr.
Suite D
Sacramento,  CA  95827
Correspondent Contact ERIC S HOY
Regulation Number866.5100
Classification Product Code
LLL  
Date Received12/08/1995
Decision Date 04/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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