Device Classification Name |
Radioimmunoassay, Testosterones And Dihydrotestosterone
|
510(k) Number |
K182521 |
Device Name |
FastPack IP Sex Hormone Binding Globulin Immunoassay |
Applicant |
Qualigen, Inc. |
2042 Corte Del Nogal |
Carlsbad,
CA
92011
|
|
Applicant Contact |
Wajdi Abdul-Ahad |
Correspondent |
Qualigen, Inc. |
2042 Corte Del Nogal |
Carlsbad,
CA
92011
|
|
Correspondent Contact |
Wajdi Abdul-Ahad |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 09/13/2018 |
Decision Date | 01/29/2019 |
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
|
|
|