DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H

Transferrin, Antigen, Antiserum, Control

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Trf Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control L,control M, Control H.

Pre-market Notification Details

Device IDK063322
510k NumberK063322
Device Name:DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H
ClassificationTransferrin, Antigen, Antiserum, Control
Applicant DADE BEHRING, INC. GLASGOW SITE, PO BOX 6101 Newark,  DE  19714 -6101
ContactKathleen Dray-lyons
CorrespondentKathleen Dray-lyons
DADE BEHRING, INC. GLASGOW SITE, PO BOX 6101 Newark,  DE  19714 -6101
Product CodeDDG  
Subsequent Product CodeJIX
Subsequent Product CodeJJY
CFR Regulation Number866.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-03
Decision Date2007-01-24
Summary:summary

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