ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT

Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

OSMETECH MOLECULAR DIAGNOSTICS

The following data is part of a premarket notification filed by Osmetech Molecular Diagnostics with the FDA for Esensor Warfarin Sensitivity And Xt-8 Instrument.

Pre-market Notification Details

Device IDK073720
510k NumberK073720
Device Name:ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT
ClassificationCytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Applicant OSMETECH MOLECULAR DIAGNOSTICS 757 SOUTH RAYMOND AVE. Pasadena,  CA  91105
ContactRobert Dicheck
CorrespondentRobert Dicheck
OSMETECH MOLECULAR DIAGNOSTICS 757 SOUTH RAYMOND AVE. Pasadena,  CA  91105
Product CodeODW  
Subsequent Product CodeNSU
Subsequent Product CodeODV
CFR Regulation Number862.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-31
Decision Date2008-07-17
Summary:summary

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