IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER

Igg (gamma Chain Specific), Antigen, Antiserum, Control

THE BINDING SITE, LTD.

The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Igg Subclass Single Dilution Diagnostic Kit For Use With The Beckman Array Analyzer.

Pre-market Notification Details

Device IDK940422
510k NumberK940422
Device Name:IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
ClassificationIgg (gamma Chain Specific), Antigen, Antiserum, Control
Applicant THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica,  CA  90404
ContactJay H Geller
CorrespondentJay H Geller
THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica,  CA  90404
Product CodeDFZ  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-19
Decision Date1994-05-27

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