Device Classification Name |
Radioimmunoassay, Testosterones And Dihydrotestosterone
|
510(k) Number |
K021972 |
Device Name |
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY |
Applicant |
Qualigen, Inc. |
2042 CORTE DEL NOGAL |
CARLSBAD,
CA
92009
|
|
Applicant Contact |
DOROTHY DEINZER |
Correspondent |
Qualigen, Inc. |
2042 CORTE DEL NOGAL |
CARLSBAD,
CA
92009
|
|
Correspondent Contact |
DOROTHY DEINZER |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 06/17/2002 |
Decision Date | 08/21/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|