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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Antitrypsin, Antigen, Antiserum, Control
510(k) Number K123256
Device Name HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
Applicant
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Applicant Contact JILL CONSTANTINE
Correspondent
The Binding Site Group , Ltd.
8 Calthorpe Rd.
Birmingham,  GB B15 1QT
Correspondent Contact JILL CONSTANTINE
Regulation Number866.5130
Classification Product Code
DEM  
Date Received10/18/2012
Decision Date 07/03/2013
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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