510(k) K132750

Device

ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY

Applicant

ILLUMINA, INC.

510(k) number

K132750

Product code

PFS  

Decision

Substantially Equivalent (SESE)

Decision date

2013-11-19

Date received

2013-09-03

Regulation

866.5900

Classification name

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

Medical specialty

Immunology

Review panel

Pathology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No