VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

Ortho-Clinical Diagnostics, Inc.

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

Pre-market Notification Details

Device IDK063144
510k NumberK063144
Device Name:VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
ContactSarah C Parsons
CorrespondentSarah C Parsons
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester,  NY  14626 -5101
Product CodeJJE  
Subsequent Product CodeJIT
Subsequent Product CodeLBR
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-16
Decision Date2006-11-13
Summary:summary

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