DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)

Calibrator, Multi-analyte Mixture

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Enzyme 1 Calibrator (enz 1 Cal - Kc310).

Pre-market Notification Details

Device IDK061923
510k NumberK061923
Device Name:DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
ClassificationCalibrator, Multi-analyte Mixture
Applicant DADE BEHRING, INC. P.O. BOX 6101 Newark,  DE  19714
ContactVictor M Carrio
CorrespondentVictor M Carrio
DADE BEHRING, INC. P.O. BOX 6101 Newark,  DE  19714
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-07
Decision Date2006-08-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768015861 K061923 000

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