Device Classification Name |
Radioimmunoassay, Free Thyroxine
|
510(k) Number |
K140842 |
Device Name |
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART |
Applicant |
Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 |
M/S 514 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
FRANCES A DILLON |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 |
M/S 514 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
FRANCES A DILLON |
Regulation Number | 862.1695
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/02/2014 |
Decision Date | 11/26/2014 |
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
|
|
|