CELL-DYN EMERALD SYSTEM


Device Classification Name

counter, differential cell

510(k) Number K081495
Device Name CELL-DYN EMERALD SYSTEM
Applicant
ABBOTT LABORATORIES
5440 patrick henry dr.
santa clara, 
CA 
95054

Applicant Contact michelle b roeding
Correspondent
ABBOTT LABORATORIES
5440 patrick henry dr.
santa clara, 
CA 
95054

Correspodent Contact michelle b roeding
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 05/29/2008
Decision Date 02/04/2009
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

Recalls CDRH Recalls