VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS

System, Test, Rheumatoid Factor

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 Rf Reagent, Vitros Chemistry Products Calibrator Kit 16, Vitros Chemistry Products Fs.

Pre-market Notification Details

Device IDK041863
510k NumberK041863
Device Name:VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS
ClassificationSystem, Test, Rheumatoid Factor
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 CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-09
Decision Date2004-09-20
Summary:summary

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