510(k) K050063

Device

PROSTATE-63 CANCER DIAGNOSTIC TEST

Applicant

ASYMMETRX

510(k) number

K050063

Product code

NTR  

Decision

Substantially Equivalent (SESE)

Decision date

2005-02-09

Date received

2005-01-11

Regulation

864.1860

Classification name

Immunohistochemical Reagent, Antibody (monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells

Medical specialty

Hematology

Review panel

Pathology

Device class

1

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No