Device Classification Name |
radioimmunoassay, cortisol
|
510(k) Number |
K203270 |
Device Name |
IMMULITE/IMMULITE® 1000 Cortisol |
Applicant |
Siemens Healthcare Diagnostics Products Ltd. |
Glyn Rhonwy |
Llanberis,
GB
LL55 4EL
|
|
Applicant Contact |
Malgorzata Robak |
Correspondent |
Siemens Healthcare Diagnostics Products Ltd. |
Glyn Rhonwy, Llanberis |
Caernarfon,
GB
LL55 4EL
|
|
Correspondent Contact |
Malgorzata Robak |
Regulation Number | 862.1205
|
Classification Product Code |
|
Date Received | 11/05/2020 |
Decision Date | 01/15/2021 |
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
|
|
|