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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K013285
Device Name RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
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 Number866.5660
Classification Product Code
MOB  
Date Received10/02/2001
Decision Date 11/14/2001
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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