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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 K963275
Device Name RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
Applicant
Immuno Concepts, Inc.
2280 Springlake Rd.
Suite 106
Dallas,  TX  75234
Applicant Contact ERIC S HOY
Correspondent
Immuno Concepts, Inc.
2280 Springlake Rd.
Suite 106
Dallas,  TX  75234
Correspondent Contact ERIC S HOY
Regulation Number866.5100
Classification Product Code
LLL  
Date Received08/20/1996
Decision Date 09/13/1996
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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