VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2

Electrode, Ion Specific, Potassium

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 K+ Slides And Calibrator Kit 2.

Pre-market Notification Details

Device IDK073157
510k NumberK073157
Device Name:VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
ClassificationElectrode, Ion Specific, Potassium
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactMarlene Hanna
CorrespondentMarlene Hanna
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeCEM  
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-08
Decision Date2007-12-07
Summary:summary

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