CELL-DYN EMERALD 22 SYSTEM


Device Classification Name

counter, differential cell

510(k) Number K110381
Device Name CELL-DYN EMERALD 22 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 02/10/2011
Decision Date 12/22/2011
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