CELL-DYN 1800 SYSTEM


Device Classification Name

counter, differential cell

510(k) Number K030513
Device Name CELL-DYN 1800 SYSTEM
Applicant
ABBOTT LABORATORIES
5440 patrick henry dr.
santa clara, 
CA 
95054

Applicant Contact john dean
Correspondent
ABBOTT LABORATORIES
5440 patrick henry dr.
santa clara, 
CA 
95054

Correspodent Contact john dean
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 02/19/2003
Decision Date 05/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls