Device Classification Name |
Radioimmunoassay, Testosterones And Dihydrotestosterone
|
510(k) Number |
K932951 |
Device Name |
DELFIA TESTTOSTERONE KIT |
Applicant |
WALLAC OY |
P.O. BOX 10 |
SF-20101 TURKU |
FINLAND,
FI
|
|
Applicant Contact |
GUNNEL LAAKSONEN |
Correspondent |
WALLAC OY |
P.O. BOX 10 |
SF-20101 TURKU |
FINLAND,
FI
|
|
Correspondent Contact |
GUNNEL LAAKSONEN |
Regulation Number | 862.1680
|
Classification Product Code |
|
Date Received | 06/17/1993 |
Decision Date | 08/03/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|