VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III

Urinary Homocystine (nonquantitative) Test System

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 Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers I, Ii And Iii.

Pre-market Notification Details

Device IDK123930
510k NumberK123930
Device Name:VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
ClassificationUrinary Homocystine (nonquantitative) Test System
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactMichael M Byrne
CorrespondentMichael M Byrne
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeLPS  
CFR Regulation Number862.1377 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-20
Decision Date2013-05-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750030163 K123930 000

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