Device Classification Name |
system, cystic fibrosis transmembrane conductance regulator, gene mutation detection
|
510(k) Number |
K083846 |
Device Name |
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 |
Applicant |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. |
TORONTO, ONTARIO,
CA
M5G 1Y8
|
|
Applicant Contact |
GLORIA LEE |
Correspondent |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
439 UNIVERSITY AVE. |
TORONTO, ONTARIO,
CA
M5G 1Y8
|
|
Correspondent Contact |
GLORIA LEE |
Regulation Number | 866.5900
|
Classification Product Code |
|
Date Received | 12/24/2008 |
Decision Date | 09/01/2009 |
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
|
|
|