VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258

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+dt Slides: Vitros Chemistry Products Dt Calibrator Kit, Model K+dt Slides: 153 2258.

Pre-market Notification Details

Device IDK083680
510k NumberK083680
Device Name:VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258
ClassificationElectrode, Ion Specific, Potassium
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. MC 00882 Rochester,  NY  14626 -5101
ContactMarlene A Hanna
CorrespondentMarlene A Hanna
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. MC 00882 Rochester,  NY  14626 -5101
Product CodeCEM  
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-12
Decision Date2009-02-27
Summary:summary

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