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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 K983390
Device Name IS-ANTI-MPO IGG ELISA TEST SYSTEM
Applicant
Columbia Bioscience, Inc.
8775 M Centre Park Dr.
#559
Columbia,  MD  21045
Applicant Contact NORMAN JENKINS
Correspondent
Columbia Bioscience, Inc.
8775 M Centre Park Dr.
#559
Columbia,  MD  21045
Correspondent Contact NORMAN JENKINS
Regulation Number866.5660
Classification Product Code
MOB  
Date Received09/25/1998
Decision Date 11/18/1998
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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