CELLAVISION DM96 WITH THE BODY FLUID APPLICATION


Device Classification Name

device, automated cell-locating

510(k) Number K080595
Device Name CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
Applicant
CELLAVISION AB
6740 riverview terrace
minneapolis, 
MN 
55432

Applicant Contact constance g bundy
Correspondent
CELLAVISION AB
6740 riverview terrace
minneapolis, 
MN 
55432

Correspodent Contact constance g bundy
Regulation Number 864.5260
Classification Product Code
JOY  
Subsequent Product Code
GKZ  
Date Received 03/03/2008
Decision Date 12/05/2008
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