Device Classification Name |
Radioimmunoassay, Testosterones And Dihydrotestosterone
|
510(k) Number |
K964889 |
Device Name |
ELECSYS TESTOSTERONE ASSAY |
Applicant |
BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. |
P.O. BOX 4117 |
CONCORD,
CA
94524 -4117
|
|
Applicant Contact |
YVETTE LLODY |
Correspondent |
BOEHRINGER MANNHEIM CORP. |
2400 BISSO LN. |
P.O. BOX 4117 |
CONCORD,
CA
94524 -4117
|
|
Correspondent Contact |
YVETTE LLODY |
Regulation Number | 862.1680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/06/1996 |
Decision Date | 03/18/1997 |
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
|
|
|