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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 K090920
Device Name HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
Applicant
THE BINDING SITE, LTD.
WEST TOWER, SUITE 4000
2425 WEST OLYMPIC BOULEVARD
SANTA MONICA,  CA  90404
Applicant Contact JAY H GELLER
Correspondent
THE BINDING SITE, LTD.
WEST TOWER, SUITE 4000
2425 WEST OLYMPIC BOULEVARD
SANTA MONICA,  CA  90404
Correspondent Contact JAY H GELLER
Regulation Number866.5510
Classification Product Code
CFN  
Date Received04/01/2009
Decision Date 12/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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