DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220

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 System Lipid Calibrator, Model Kc220.

Pre-market Notification Details

Device IDK061750
510k NumberK061750
Device Name:DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
ClassificationCalibrator, Multi-analyte Mixture
Applicant DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark,  DE  19714 -6101
ContactVictor M Carrio
CorrespondentVictor M Carrio
DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark,  DE  19714 -6101
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-21
Decision Date2006-08-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768020452 K061750 000

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