DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR

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 System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator.

Pre-market Notification Details

Device IDK073561
510k NumberK073561
Device Name:DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
ClassificationMethod, Nephelometric, Immunoglobulins (g, A, M)
Applicant DADE BEHRING, INC. P.O BOX 6101, MS514 Newark,  DE  19714 -6101
ContactHelen M Lee
CorrespondentHelen M Lee
DADE BEHRING, INC. P.O BOX 6101, MS514 Newark,  DE  19714 -6101
Product CodeCFN  
Subsequent Product CodeJIX
Subsequent Product CodeJJY
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-19
Decision Date2008-02-26
Summary:summary

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