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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transferrin, antigen, antiserum, control
510(k) Number K120236
Device Name TRANSFERRIN KIT FOR USE ON THE SPAPLUS
Applicant
THE BINDING SITE GROUP LTD
8 CALTHORPE ROAD
EDGBASTON
birmingham, west midlands,  GB b15 1qt
Applicant Contact jill constantine
Correspondent
THE BINDING SITE GROUP LTD
8 CALTHORPE ROAD
EDGBASTON
birmingham, west midlands,  GB b15 1qt
Correspondent Contact jill constantine
Regulation Number866.5880
Classification Product Code
DDG  
Date Received01/26/2012
Decision Date 02/13/2013
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
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