Device Classification Name |
Counter, Differential Cell
|
510(k) Number |
K162977 |
Device Name |
ADVIA 2120i, ADVIA 2120 |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 BENEDICT AVENUE |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
Gerard Sadrakula |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS |
511 BENEDICT AVENUE |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
Gerard Sadrakula |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 10/26/2016 |
Decision Date | 08/11/2017 |
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
|
Recalls |
CDRH Recalls
|
|
|