COULTER CELLPREP


Device Classification Name

apparatus, automated blood cell diluting

510(k) Number K021150
Device Name COULTER CELLPREP
Original Applicant
BECKMAN COULTER, INC.
11800 sw 147th ave.
m/s 31-b06
miami, 
FL 
33196 -2500

Original Contact lourdes coba
Regulation Number 864.5240
Classification Product Code
GKH  
Date Received 04/10/2002
Decision Date 06/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No