Device Classification Name |
radioimmunoassay, testosterones and dihydrotestosterone
|
510(k) Number |
K802728 |
Device Name |
125I-TESTOSTERONE TEST SET |
Applicant |
WIEN LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
WIEN LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 11/03/1980 |
Decision Date | 12/11/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|