ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD


Device Classification Name

counter, cell, automated (particle counter)

510(k) Number K022331
Device Name ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
Original Applicant
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Original Contact kenneth t edds
Regulation Number 864.5200
Classification Product Code
GKL  
Subsequent Product Codes
GKZ   JPK  
Date Received 07/18/2002
Decision Date 09/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No