PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS


Device Classification Name

microscope, automated, image analysis, operator intervention

510(k) Number K080910
Device Name PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
Applicant
BIOIMAGENE, INC.
1601 s. de anza blvd
suite 212
cupertino, 
CA 
95014

Applicant Contact indu lakshman
Correspondent
BIOIMAGENE, INC.
1601 s. de anza blvd
suite 212
cupertino, 
CA 
95014

Correspodent Contact indu lakshman
Regulation Number 864.1860
Classification Product Code
NOT  
Date Received 04/01/2008
Decision Date 02/04/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Pathology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No