VITROS Chemistry Products Calibrator Kit 3

Calibrator, Multi-analyte Mixture

ORTHO-CLINICAL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Calibrator Kit 3.

Pre-market Notification Details

Device IDK161140
510k NumberK161140
Device Name:VITROS Chemistry Products Calibrator Kit 3
ClassificationCalibrator, Multi-analyte Mixture
Applicant ORTHO-CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DRIVE Rochester,  NY  14626 -5101
ContactMarlene Hanna
CorrespondentMarlene Hanna
ORTHO-CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DRIVE Rochester,  NY  14626 -5101
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-22
Decision Date2016-05-20
Summary:summary

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