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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C4, Antigen, Antiserum, Control
510(k) Number K100455
Device Name SPAPLUS ANALYZER
Applicant
The Binding Site
12100 Wilshire Blvd.
Suite 500
Los Angeles,  CA  90025
Applicant Contact JAY GELLER
Correspondent
The Binding Site
12100 Wilshire Blvd.
Suite 500
Los Angeles,  CA  90025
Correspondent Contact JAY GELLER
Regulation Number866.5240
Classification Product Code
DBI  
Date Received02/17/2010
Decision Date 09/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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