Device Classification Name |
radioimmunoassay, testosterones and dihydrotestosterone
|
510(k) Number |
K201908 |
Device Name |
LIAISON Testosterone xt |
Applicant |
DiaSorin Inc. |
1951 Northwestern Avenue |
Stillwater,
MN
55082
|
|
Applicant Contact |
John Walter |
Correspondent |
DiaSorin Inc. |
1951 Northwestern Avenue |
Stillwater,
MN
55082
|
|
Correspondent Contact |
Mari Meyer |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 07/09/2020 |
Decision Date | 10/15/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|