VITROS CHEMISTRY PRODUCTS ECO2 SLIDES

Enzymatic, Carbon-dioxide

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 Eco2 Slides.

Pre-market Notification Details

Device IDK120765
510k NumberK120765
Device Name:VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
ClassificationEnzymatic, Carbon-dioxide
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactGaozhen Hang
CorrespondentGaozhen Hang
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeKHS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-13
Decision Date2012-10-24
Summary:summary

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