Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K140505 |
Device Name |
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL |
Applicant |
Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVENUE |
TARRYTOWN,
NY
10591 -5097
|
|
Applicant Contact |
FATIMA PACHECO |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVENUE |
TARRYTOWN,
NY
10591 -5097
|
|
Correspondent Contact |
FATIMA PACHECO |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 02/27/2014 |
Decision Date | 03/31/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|