CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY


Device Classification Name

immunohistochemistry antibody assay, estrogen receptor

510(k) Number K110215
Device Name CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 east innovation park dr.
tucson, 
AZ 
85755

Applicant Contact roxane bonner
Correspondent
VENTANA MEDICAL SYSTEMS, INC.
1910 east innovation park dr.
tucson, 
AZ 
85755

Correspodent Contact roxane bonner
Regulation Number 864.1860
Classification Product Code
MYA  
Date Received 12/29/2010
Decision Date 12/17/2012
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