ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000


Device Classification Name

system, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays

510(k) Number K080909
Device Name ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
Applicant
IKONISYS INC
5 science park
suite 1000
new haven, 
CT 
06511

Applicant Contact syed ataullah
Correspondent
IKONISYS INC
5 science park
suite 1000
new haven, 
CT 
06511

Correspodent Contact syed ataullah
Regulation Number 866.4700
Classification Product Code
NTH  
Date Received 04/01/2008
Decision Date 10/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Pathology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No