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

Method, Nephelometric, Immunoglobulins (g, A, M)

DADE BEHRING, INC.

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

Pre-market Notification Details

Device IDK061845
510k NumberK061845
Device Name:DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
ClassificationMethod, Nephelometric, Immunoglobulins (g, A, M)
Applicant DADE BEHRING, INC. P.O. BOX 6101 Newark,,  DE  19714
ContactKathleen Dray-lyons
CorrespondentKathleen Dray-lyons
DADE BEHRING, INC. P.O. BOX 6101 Newark,,  DE  19714
Product CodeCFN  
Subsequent Product CodeJIX
Subsequent Product CodeJJY
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-29
Decision Date2006-08-24
Summary:summary

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