DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)

Calibrator, Secondary

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Ferritin Flex Reagent Cartridge (ferr).

Pre-market Notification Details

Device IDK070552
510k NumberK070552
Device Name:DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
ClassificationCalibrator, Secondary
Applicant DADE BEHRING, INC. P.O. BOX 6101 MS 514 Newark,  DE  19714
ContactLorraine H Piestrak
CorrespondentLorraine H Piestrak
DADE BEHRING, INC. P.O. BOX 6101 MS 514 Newark,  DE  19714
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-27
Decision Date2007-04-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768015182 K070552 000

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