Device Classification Name |
Radioimmunoassay, Thyroid-Stimulating Hormone
|
510(k) Number |
K151792 |
Device Name |
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System |
Applicant |
Siemens Healthcare Diagnostics,Inc. |
511 Benedict Avenue |
Tarrytown,
NY
10591
|
|
Applicant Contact |
Philip Liu |
Correspondent |
Siemens Healthcare Diagnostics,Inc. |
511 Benedict Avenue |
Tarrytown,
NY
10591
|
|
Correspondent Contact |
Philip Liu |
Regulation Number | 862.1690
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/01/2015 |
Decision Date | 11/20/2015 |
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
|
|
|