510(k) K124006

Device

ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY

Applicant

ILLUMINA, INC.

510(k) number

K124006

Product code

PFR  

Decision

Substantially Equivalent (SESE)

Decision date

2013-11-19

Date received

2012-12-26

Regulation

866.5900

Classification name

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

Medical specialty

Immunology

Review panel

Pathology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No