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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 K140396
Device Name FREELITE HUMAN LAMBDA FREE KIT
Applicant
The Binding Site Group , Ltd.
5889 Obderlin Dr., Suite 101
San Diego,  CA  92121
Applicant Contact DOUG KURTH
Correspondent
The Binding Site Group , Ltd.
5889 Obderlin Dr., Suite 101
San Diego,  CA  92121
Correspondent Contact DOUG KURTH
Regulation Number866.5550
Classification Product Code
DEH  
Date Received02/18/2014
Decision Date 04/16/2014
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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