Device Classification Name |
Radioimmunoassay, Testosterones And Dihydrotestosterone
|
510(k) Number |
K860003 |
Device Name |
LEECO TESTOSTERONE DIAGNOSTIC KIT |
Applicant |
LEECO DIAGNOSTICS, INC. |
21705 EVERGREEN |
P.O. BOX 5126 |
SOUTHFIELD,
MI
48075
|
|
Applicant Contact |
JAMES P LEE |
Correspondent |
LEECO DIAGNOSTICS, INC. |
21705 EVERGREEN |
P.O. BOX 5126 |
SOUTHFIELD,
MI
48075
|
|
Correspondent Contact |
JAMES P LEE |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 01/02/1986 |
Decision Date | 03/17/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|