510(k) K022177

Device

PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

Applicant

Bayer Diagnostics Corp.

510(k) number

K022177

Product code

LTJ

Decision

Substantially Equivalent (SESE)

Decision date

2002-12-17

Date received

2002-07-03

Regulation

866.6010

Classification name

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Medical specialty

Immunology

Review panel

Immunology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N