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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 (Enzyme-Labeled), Antigen, Controls
510(k) Number K992041
Device Name RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
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
LJM  
Date Received06/17/1999
Decision Date 07/23/1999
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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