Device Classification Name |
Radioimmunoassay, Testosterones And Dihydrotestosterone
|
510(k) Number |
K191350 |
Device Name |
ACTIVE® Free Testosterone RIA |
Applicant |
Immunotech s.r.o. |
Radiova 1 |
Prague,
CZ
10227
|
|
Applicant Contact |
Vit Oburka |
Correspondent |
Immunotech s.r.o. |
Radiova 1 |
Prague,
CZ
10227
|
|
Correspondent Contact |
Vit Oburka |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 05/20/2019 |
Decision Date | 12/20/2019 |
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
|
|
|