Device Classification Name |
Radioimmunoassay, Testosterones And Dihydrotestosterone
|
510(k) Number |
K862483 |
Device Name |
PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT |
Applicant |
PANTEX, DIV. BIO-ANALYSIS, INC. |
1737 21ST ST. |
SANTA MONICA,
CA
90404
|
|
Applicant Contact |
NEIL CHIAMORI |
Correspondent |
PANTEX, DIV. BIO-ANALYSIS, INC. |
1737 21ST ST. |
SANTA MONICA,
CA
90404
|
|
Correspondent Contact |
NEIL CHIAMORI |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 06/30/1986 |
Decision Date | 01/14/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|