Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K133128 |
Device Name |
IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION |
Applicant |
Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
Asha Gartland |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
Asha Gartland |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 09/30/2013 |
Decision Date | 10/22/2013 |
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
|
|
|