Device Classification Name |
radioimmunoassay, testosterones and dihydrotestosterone
|
510(k) Number |
K014120 |
Device Name |
TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) |
Applicant |
DIAGNOSTICS BIOCHEM CANADA, INC. |
1020 HARGRIEVE RD. |
LONDON, ONTARIO,
CA
N6E 1P5
|
|
Applicant Contact |
G. R. DUMONT |
Correspondent |
DIAGNOSTICS BIOCHEM CANADA, INC. |
1020 HARGRIEVE RD. |
LONDON, ONTARIO,
CA
N6E 1P5
|
|
Correspondent Contact |
G. R. DUMONT |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 12/17/2001 |
Decision Date | 02/08/2002 |
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
|
|
|