HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER

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 Human Igg Subclass Liquid Reagent Kits For Use On The Hitachi 911/7070 Turbidimetric Analyser.

Pre-market Notification Details

Device IDK021081
510k NumberK021081
Device Name:HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER
ClassificationIgg (gamma Chain Specific), Antigen, Antiserum, Control
Applicant THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD Santa Monica,  CA  90404
ContactJay H Geller
CorrespondentJay H Geller
THE BINDING SITE, LTD. WEST TOWER, SUITE 4000 2425 WEST OLYMPIC BOULEVARD Santa Monica,  CA  90404
Product CodeDFZ  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-03
Decision Date2002-06-17

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