CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY


Device Classification Name

immunohistochemistry assay,antibody,progesterone receptor

510(k) Number K103818
Device Name CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant
VENTANA MEDICAL SYTEMS, INC
1910 e. innovations park drive
tucson, 
AZ 
85755

Applicant Contact george de la rosa
Correspondent
VENTANA MEDICAL SYTEMS, INC
1910 e. innovations park drive
tucson, 
AZ 
85755

Correspodent Contact george de la rosa
Regulation Number 864.1860
Classification Product Code
MXZ  
Date Received 12/29/2010
Decision Date 11/16/2011
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