510(k) K213510

Device

IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA

Applicant

Siemens Healthcare Diagnostics Products, Ltd.

510(k) number

K213510

Product code

LTK

Decision

Substantially Equivalent (SESE)

Decision date

2023-09-08

Date received

2021-11-02

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