RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER


Device Classification Name

counter, differential cell

510(k) Number K050589
Device Name RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
Applicant
SYSMEX AMERICA, INC.
one nelson c. white parkway
mundelein, 
IL 
60060

Applicant Contact nina gamperling
Correspondent
SYSMEX AMERICA, INC.
one nelson c. white parkway
mundelein, 
IL 
60060

Correspodent Contact nina gamperling
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 03/08/2005
Decision Date 05/04/2005
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