VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927

Electrode, Ion Specific, Sodium

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 Na + Dt Slides, Model 153 2290 And Dt Calibrator Kit, Model 195 7927.

Pre-market Notification Details

Device IDK091861
510k NumberK091861
Device Name:VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
ClassificationElectrode, Ion Specific, Sodium
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactMarlene A Hanna
CorrespondentMarlene A Hanna
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeJGS  
CFR Regulation Number862.1665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-19
Decision Date2009-09-03
Summary:summary

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