Device Classification Name |
radioimmunoassay, testosterones and dihydrotestosterone
|
510(k) Number |
K181017 |
Device Name |
Free Testosterone AccuBind ELISA Test System |
Applicant |
Monobind Inc. |
100 North Pointe Drive |
Lake Forest,
CA
92630
|
|
Applicant Contact |
Anthony Shatola |
Correspondent |
Monobind Inc. |
100 North Pointe Drive |
Lake Forest,
CA
92630
|
|
Correspondent Contact |
Anthony Shatola |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 04/10/2018 |
Decision Date | 07/20/2018 |
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
|
|
|