MODIFICATION TO DUET SYSTEM


Device Classification Name

device, automated cell-locating

510(k) Number K050840
Device Name MODIFICATION TO DUET SYSTEM
Applicant
BIOVIEW LTD.
11 menachem begin st.
ramat-gan, 

IL

52521

Applicant Contact dorit winitz
Correspondent
BIOVIEW LTD.
11 menachem begin st.
ramat-gan, 

IL

52521

Correspodent Contact dorit winitz
Regulation Number 864.5260
Classification Product Code
JOY  
Date Received 04/01/2005
Decision Date 08/16/2005
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