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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 K981030
Device Name BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
Applicant
The Binding Site, Ltd.
East Tower, Suite 600
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Applicant Contact JAY H GELLER
Correspondent
The Binding Site, Ltd.
East Tower, Suite 600
2425 W. Olympic Blvd.
Santa Monica,  CA  90404
Correspondent Contact JAY H GELLER
Regulation Number866.5660
Classification Product Code
MOB  
Date Received03/19/1998
Decision Date 07/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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