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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Lambda, Antigen, Antiserum, Control
510(k) Number K010440
Device Name FREELITE LAMBDA FREE KIT
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
DEH  
Date Received02/13/2001
Decision Date 04/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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