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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kappa, antigen, antiserum, control
510(k) Number K062372
Device Name FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
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 Number866.5550
Classification Product Code
DFH  
Subsequent Product Code
DEH  
Date Received08/14/2006
Decision Date 06/21/2007
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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