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510(k) Premarket Notification Database

Device Classification Name igg (gamma chain specific), antigen, antiserum, control
510(k) NumberK940422
Device NameIGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
Applicant
THE BINDING SITE, LTD.
east tower, suite 600
2425 west olympic boulevard
santa monica,  CA  90404
Contactjay h geller
Regulation Number866.5510
Classification Product Code
DFZ
Date Received01/19/1994
Decision Date 05/27/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Statement/Summary/Purged Status Statement only
Type Traditional
Reviewed by Third Party No
Expedited Review

Database Updated 01/16/2009

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