510(k) K100321

Device

DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

Applicant

SIEMENS HEALTHCARE DIAGNOSTICS

510(k) number

K100321

Product code

LTK  

Decision

Substantially Equivalent (SESE)

Decision date

2011-04-12

Date received

2010-02-04

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