ESENSOR WARFARIN SENSITIVITY SALIVA TEST


Device Classification Name

instrumentation for clinical multiplex test systems

510(k) Number K110786
Device Name ESENSOR WARFARIN SENSITIVITY SALIVA TEST
Applicant
GENMARK DIAGNOSTICS, INC
5964 la place court
suite 100
carlsbad, 
CA 
92008

Applicant Contact john riolo
Correspondent
GENMARK DIAGNOSTICS, INC
5964 la place court
suite 100
carlsbad, 
CA 
92008

Correspodent Contact john riolo
Regulation Number 862.2570
Classification Product Code
NSU  
Subsequent Product Codes
ODV   ODW  
Date Received 03/22/2011
Decision Date 12/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No