Device Classification Name |
counter, differential cell
|
510(k) Number |
K090346 |
Device Name |
ADVIA 2120/2120I BODY FLUIDS |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue |
Tarrytown,
NY
10591
|
|
Applicant Contact |
Ernest Joseph |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue |
Tarrytown,
NY
10591
|
|
Correspondent Contact |
Ernest Joseph |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 02/11/2009 |
Decision Date | 07/28/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|