DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125

Diazo Colorimetry, Bilirubin

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Dbil Flex Reagent Cartridge, Model K2125.

Pre-market Notification Details

Device IDK061839
510k NumberK061839
Device Name:DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125
ClassificationDiazo Colorimetry, Bilirubin
Applicant DADE BEHRING, INC. P.O. BOX 6101 MS 514 Newark,  DE  19714 -6101
ContactGeorge M Plummer
CorrespondentGeorge M Plummer
DADE BEHRING, INC. P.O. BOX 6101 MS 514 Newark,  DE  19714 -6101
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-29
Decision Date2006-08-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768015649 K061839 000

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