ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT


Device Classification Name

cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system

510(k) Number K073720
Device Name ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT
Applicant
OSMETECH MOLECULAR DIAGNOSTICS
757 south raymond ave.
pasadena, 
CA 
91105

Applicant Contact robert dicheck
Correspondent
OSMETECH MOLECULAR DIAGNOSTICS
757 south raymond ave.
pasadena, 
CA 
91105

Correspodent Contact robert dicheck
Regulation Number 862.3360
Classification Product Code
ODW  
Subsequent Product Codes
NSU   ODV  
Date Received 12/31/2007
Decision Date 07/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No