DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR

Radioassay, Vitamin B12

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Vitamin B12 And Folate Flex Reagent Cartridges And Loci 4 Calibrator.

Pre-market Notification Details

Device IDK071224
510k NumberK071224
Device Name:DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
ClassificationRadioassay, Vitamin B12
Applicant DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark,  DE  19714 -6101
ContactLorraine H Piestrak
CorrespondentLorraine H Piestrak
DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark,  DE  19714 -6101
Product CodeCDD  
Subsequent Product CodeCGN
Subsequent Product CodeJIX
CFR Regulation Number862.1810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-02
Decision Date2007-11-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768016653 K071224 000

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