SCANVIEW, MODEL SC-300

Device Classification Name

device, automated cell-locating

510(k) Number K071398
Device Name SCANVIEW, MODEL SC-300
Applicant
APPLIED SPECTRAL IMAGING, LTD.
hamatechet st 4.
ramat gavriel, 

IL

10551

Applicant Contact silvia stolarski
Correspondent
APPLIED SPECTRAL IMAGING, LTD.
hamatechet st 4.
ramat gavriel, 

IL

10551

Correspodent Contact silvia stolarski
Regulation Number 864.5260
Classification Product Code
JOY  
Date Received 05/21/2007
Decision Date 10/04/2007
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