Device Classification Name |
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
|
510(k) Number |
K124006 |
Device Name |
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY |
Applicant |
ILLUMINA, INC. |
5200 ILLUMINA WAY |
SAN DIEGO,
CA
92122
|
|
Applicant Contact |
LEANNE M KIVIHARJU |
Correspondent |
ILLUMINA, INC. |
5200 ILLUMINA WAY |
SAN DIEGO,
CA
92122
|
|
Correspondent Contact |
LEANNE M KIVIHARJU |
Regulation Number | 866.5900
|
Classification Product Code |
|
Date Received | 12/26/2012 |
Decision Date | 11/19/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|