DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH

System, Test, Beta-2-microglobulin Immunological

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista B2mic Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium, Control High.

Pre-market Notification Details

Device IDK063272
510k NumberK063272
Device Name:DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
ClassificationSystem, Test, Beta-2-microglobulin Immunological
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 CodeJZG  
Subsequent Product CodeJIX
Subsequent Product CodeJJY
CFR Regulation Number866.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-30
Decision Date2007-01-26
Summary:summary

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