DUET SYSTEM


Device Classification Name

device, automated cell-locating

510(k) Number K030192
Device Name DUET SYSTEM
Original Applicant
BIOVIEW LTD.
117 ahuzah st.
ra’ananna, 

IL

76703

Original Contact orly maor
Regulation Number 864.5260
Classification Product Code
JOY  
Date Received 01/21/2003
Decision Date 08/20/2003
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