510(k) K022329

Device

CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

Applicant

BAYER DIAGNOSTICS CORP.

510(k) number

K022329

Product code

LTK  

Decision

Substantially Equivalent (SESE)

Decision date

2002-11-27

Date received

2002-07-18

Regulation

866.6010

Classification name

Test, Epithelial Ovarian Tumor-associated Antigen (ca125)

Medical specialty

Immunology

Review panel

Immunology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No