510(k) K072794

Device

IMMULITE 2500 OM-MA, MODEL L5KOP

Applicant

Siemens Medical Solutions Diagnostics

510(k) number

K072794

Product code

LTK

Decision

Substantially Equivalent (SESE)

Decision date

2007-11-05

Date received

2007-10-01

Regulation

866.6010

Classification name

Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

Medical specialty

Immunology

Review panel

Immunology

Device class

2

Clearance type

Special

Statement or summary

Summary

Third party reviewed

N