Device Classification Name |
radioimmunoassay, free thyroxine
|
510(k) Number |
K132249 |
Device Name |
ADVIA CENTAUR FT4, ADVIA CENTAUR T4 |
Applicant |
Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
MATTEW GEE |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
MATTEW GEE |
Regulation Number | 862.1695
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/19/2013 |
Decision Date | 09/13/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|