Device Classification Name |
system, test, immunological, antigen, tumor
|
510(k) Number |
K233946 |
Device Name |
IMMULITE® 2000 BR-MA |
Applicant |
Siemens Healthcare Diagnostics Products Ltd |
Glyn Rhonwy, Llanberis |
Caernarfon |
Llanberis,
GB
LL55 4EL
|
|
Applicant Contact |
Karlyn Kellogg |
Correspondent |
Siemens Healthcare Diagnostics Products Ltd |
Glyn Rhonwy, Llanberis |
Caernarfon |
Llanberis,
GB
LL55 4EL
|
|
Correspondent Contact |
Karlyn Kellogg |
Regulation Number | 866.6010
|
Classification Product Code |
|
Date Received | 12/14/2023 |
Decision Date | 03/13/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|