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

Immunochemical, Ceruloplasmin

DADE BEHRING, INC.

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

Pre-market Notification Details

Device IDK063655
510k NumberK063655
Device Name:DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH
ClassificationImmunochemical, Ceruloplasmin
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 CodeCHN  
Subsequent Product CodeJIX
Subsequent Product CodeJJY
CFR Regulation Number866.5210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-08
Decision Date2007-02-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768006074 K063655 000

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