510(k) K040898

Device

CELLSEARCH EPITHELIAL CELL CONTROL KIT

Applicant

VERIDEX, LLC

510(k) number

K040898

Product code

NRS  

Decision

Substantially Equivalent (SESE)

Decision date

2004-06-28

Date received

2004-04-06

Regulation

864.8625

Classification name

Control Material, Blood Circulating Epithelial Cancer Cell

Medical specialty

Hematology

Review panel

Hematology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No