510(k) K221355

Device

VITROS Immuodiagnostic Products CA 125 II Reagent Pack

Applicant

Ortho Clinical Diagnostics

510(k) number

K221355

Product code

LTK

Decision

Substantially Equivalent (SESE)

Decision date

2022-12-12

Date received

2022-05-10

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