DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)

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 Chemistry 3 Calibrator (chem 3 Cal - Kc130).

Pre-market Notification Details

Device IDK062122
510k NumberK062122
Device Name:DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
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 Received2006-07-25
Decision Date2006-08-25
Summary:summary

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