MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634


Device Classification Name

immunohistochemistry antibody assay, estrogen receptor

510(k) Number K081286
Device Name MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634
Applicant
DAKO NORTH AMERICA, INC.
6392 via real
carpinteria, 
CA 
93013

Applicant Contact kelly miller
Correspondent
DAKO NORTH AMERICA, INC.
6392 via real
carpinteria, 
CA 
93013

Correspodent Contact kelly miller
Regulation Number 864.1860
Classification Product Code
MYA  
Date Received 05/07/2008
Decision Date 05/08/2009
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