Device Classification Name |
Acid, Folic, Radioimmunoassay
|
510(k) Number |
K172201 |
Device Name |
Atellica IM Folate Assay |
Applicant |
Siemens Healthcare Diagnostics Inc. |
511 Benedict Avenue |
Tarrytown,
NY
10591
|
|
Applicant Contact |
Darius Daruwala |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
511 Benedict Avenue |
Tarrytown,
NY
10591
|
|
Correspondent Contact |
Darius Daruwala |
Regulation Number | 862.1295
|
Classification Product Code |
|
Date Received | 07/21/2017 |
Decision Date | 04/12/2018 |
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
|
Recalls |
CDRH Recalls
|
|
|