Device Classification Name |
system, cystic fibrosis transmembrane conductance regulator, gene mutation detection
|
510(k) Number |
K060627 |
Device Name |
TAG-IT CYSTIC FIBROSIS KIT |
Applicant |
TM BIOSCIENCE CORPORATION |
439 UNIVERSITY AVE. |
TORONTO, ONTARIO,
CA
M5G 1Y8
|
|
Applicant Contact |
NANCY KRUNIC |
Correspondent |
TM BIOSCIENCE CORPORATION |
439 UNIVERSITY AVE. |
TORONTO, ONTARIO,
CA
M5G 1Y8
|
|
Correspondent Contact |
NANCY KRUNIC |
Regulation Number | 866.5900
|
Classification Product Code |
|
Date Received | 03/09/2006 |
Decision Date | 06/07/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|