Device Classification Name |
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
|
510(k) Number |
K063787 |
Device Name |
INPLEX CF MOLECULAR TEST |
Applicant |
THIRD WAVE TECHNOLOGIES, INC. |
502 SOUTH ROSA RD. |
MADISON,
WI
53719 -1256
|
|
Applicant Contact |
ANDREW A LUKOWIAK |
Correspondent |
THIRD WAVE TECHNOLOGIES, INC. |
502 SOUTH ROSA RD. |
MADISON,
WI
53719 -1256
|
|
Correspondent Contact |
ANDREW A LUKOWIAK |
Regulation Number | 866.5900
|
Classification Product Code |
|
Date Received | 12/21/2006 |
Decision Date | 03/13/2008 |
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
|
Recalls |
CDRH Recalls
|
|
|