ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD


Device Classification Name

counter, differential cell

510(k) Number K022668
Device Name ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
Original Applicant
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Original Contact kenneth t edds
Regulation Number 864.5220
Classification Product Code
GKZ  
Date Received 08/12/2002
Decision Date 10/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No