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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Nephelometric, Immunoglobulins (G, A, M)
510(k) Number K100588
Device Name HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
Applicant
The Binding Site Group , Ltd.
12100 Wilshire Bl., Suite 500
Los Angeles,  CA  90025
Applicant Contact JAY GELLER
Correspondent
The Binding Site Group , Ltd.
12100 Wilshire Bl., Suite 500
Los Angeles,  CA  90025
Correspondent Contact JAY GELLER
Regulation Number866.5510
Classification Product Code
CFN  
Date Received03/02/2010
Decision Date 08/16/2010
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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