SYSMEX XN-SERIES


Device Classification Name

counter, differential cell

510(k) Number K112605
Device Name SYSMEX XN-SERIES
Applicant
SYSMEX AMERICA, INC.
577 aptakisic rd
lincolnshire, 
IL 
60069

Applicant Contact sharita brooks
Correspondent
SYSMEX AMERICA, INC.
577 aptakisic rd
lincolnshire, 
IL 
60069

Correspodent Contact sharita brooks
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 09/07/2011
Decision Date 10/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No