ADVIA TESTPOINT CSF CONTROL


Device Classification Name

mixture, hematology quality control

510(k) Number K022968
Device Name ADVIA TESTPOINT CSF CONTROL
Original Applicant
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Original Contact kenneth t edds
Regulation Number 864.8625
Classification Product Code
JPK  
Date Received 09/06/2002
Decision Date 09/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No