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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name method, nephelometric, immunoglobulins (g, a, m)
510(k) Number K042152
Device Name BINDING SITE IGG SUBLCASS OLYMPUS KITS
Applicant
THE BINDING SITE
WEST TOWER, SUITE 4000
2425 WEST OLYMPIC BLVD.
SANTA MONICA,  CA  90404
Applicant Contact JAY H GELLER
Correspondent
THE BINDING SITE
WEST TOWER, SUITE 4000
2425 WEST OLYMPIC BLVD.
SANTA MONICA,  CA  90404
Correspondent Contact JAY H GELLER
Regulation Number866.5510
Classification Product Code
CFN  
Date Received08/09/2004
Decision Date 11/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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