ROCHE ONLINE TDM LIDOCAINE

Enzyme Immunoassay, Lidocaine

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Online Tdm Lidocaine.

Pre-market Notification Details

Device IDK032334
510k NumberK032334
Device Name:ROCHE ONLINE TDM LIDOCAINE
ClassificationEnzyme Immunoassay, Lidocaine
Applicant ROCHE DIAGNOSTICS CORP. P.O. BOX 50457 9115 HAGUE RD. Indianapolis,  IN  46250 -0457
ContactMike Flis
CorrespondentMike Flis
ROCHE DIAGNOSTICS CORP. P.O. BOX 50457 9115 HAGUE RD. Indianapolis,  IN  46250 -0457
Product CodeKLR  
CFR Regulation Number862.3555 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-29
Decision Date2004-01-12
Summary:summary

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