COULTER ACT 5DIFF AUTOLOADER (AL)


Device Classification Name

counter, differential cell

510(k) Number K030291
Device Name COULTER ACT 5DIFF AUTOLOADER (AL)
Original Applicant
BECKMAN COULTER, INC.
11800 sw 147th ave.
m/s 31-b06
miami, 
FL 
33196 -2500

Original Contact lourdes coba
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 01/28/2003
Decision Date 04/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls