BILIRUBIN ASSAY ON THE OMNI S ANALYZER

Bilirubin (total And Unbound) In The Neonate Test System

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Bilirubin Assay On The Omni S Analyzer.

Pre-market Notification Details

Device IDK040174
510k NumberK040174
Device Name:BILIRUBIN ASSAY ON THE OMNI S ANALYZER
ClassificationBilirubin (total And Unbound) In The Neonate Test System
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE ROAD Indianapolis,  IN  46256
ContactJennifer Tribbett
CorrespondentJennifer Tribbett
ROCHE DIAGNOSTICS CORP. 9115 HAGUE ROAD Indianapolis,  IN  46256
Product CodeMQM  
CFR Regulation Number862.1113 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-26
Decision Date2004-05-14
Summary:summary

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