Device Classification Name |
system, cystic fibrosis transmembrane conductance regulator, gene mutation detection
|
510(k) Number |
K062028 |
Device Name |
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 |
Applicant |
CELERA DIAGNOSTICS |
1401 HARBOR BAY PKWY. |
ALAMEDA,
CA
94502
|
|
Applicant Contact |
VICTORIA MACKINNON |
Correspondent |
CELERA DIAGNOSTICS |
1401 HARBOR BAY PKWY. |
ALAMEDA,
CA
94502
|
|
Correspondent Contact |
VICTORIA MACKINNON |
Regulation Number | 866.5900
|
Classification Product Code |
|
Date Received | 07/18/2006 |
Decision Date | 09/07/2007 |
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
|
|
|