Device Classification Name |
Radioimmunoassay, Testosterones And Dihydrotestosterone
|
510(k) Number |
K151529 |
Device Name |
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
500 GBC DR. P.O. BOX 6101 M/S 514 |
NEWARK,
DE
19714
|
|
Applicant Contact |
JULIE WARREN |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
500 GBC DR. P.O. BOX 6101 M/S 514 |
NEWARK,
DE
19714
|
|
Correspondent Contact |
JULIE WARREN |
Regulation Number | 862.1680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/08/2015 |
Decision Date | 02/11/2016 |
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
|
|
|