510(k) K240479

Device

Access OV Monitor

Applicant

Beckman Coulter, Inc.

510(k) number

K240479

Product code

LTK

Decision

Substantially Equivalent (SESE)

Decision date

2024-05-10

Date received

2024-02-20

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