Device Classification Name |
radioimmunoassay, thyroid-stimulating hormone
|
510(k) Number |
K141999 |
Device Name |
ADVIA CENTAUR TSH |
Applicant |
Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
Alex Hsu |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
Alex Hsu |
Regulation Number | 862.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/23/2014 |
Decision Date | 04/22/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|