THE VITROS 5,1 FS CHEMISTRY SYSTEM

Assay, Glycosylated Hemoglobin

ORTHO-CLINICAL DIAGNOSTICS

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for The Vitros 5,1 Fs Chemistry System.

Pre-market Notification Details

Device IDK041764
510k NumberK041764
Device Name:THE VITROS 5,1 FS CHEMISTRY SYSTEM
ClassificationAssay, Glycosylated Hemoglobin
Applicant ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactCarey A Mayo
CorrespondentCarey A Mayo
ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeLCP  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-30
Decision Date2004-09-09
Summary:summary

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