Device Classification Name |
system, test, thyroid autoantibody
|
510(k) Number |
K152061 |
Device Name |
IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE |
TARRYTOWN,
NY
10591
|
|
Applicant Contact |
SUSAN BROCCHI |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
511 BENEDICT AVENUE |
TARRYTOWN,
NY
10591
|
|
Correspondent Contact |
SUSAN BROCCHI |
Regulation Number | 866.5870
|
Classification Product Code |
|
Date Received | 07/24/2015 |
Decision Date | 03/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|