SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I


Device Classification Name

counter, differential cell

510(k) Number K021241
Device Name SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
Original Applicant
SYSMEX CORPORATION OF AMERICA
6699 wildlife way
long grove, 
IL 
60047 -9596

Original Contact nina m gamperling’
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 04/19/2002
Decision Date 06/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls