Device Classification Name |
radioimmunoassay, thyroid-stimulating hormone
|
510(k) Number |
K233050 |
Device Name |
ADVIA Centaur® TSH3-Ultra II (TSH3ULII) |
Applicant |
Siemens Healthcare Diagnostics, Inc. |
511 Benedict Avenue |
Tarrytown,
NY
10591
|
|
Applicant Contact |
Kelly Scuderi |
Correspondent |
Siemens Healthcare Diagnostics, Inc. |
511 Benedict Avenue |
Tarrytown,
NY
10591
|
|
Correspondent Contact |
Kelly Scuderi |
Regulation Number | 862.1690
|
Classification Product Code |
|
Date Received | 09/25/2023 |
Decision Date | 04/04/2024 |
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
|
|
|