Device Classification Name |
radioimmunoassay, testosterones and dihydrotestosterone
|
510(k) Number |
K021326 |
Device Name |
VIDAS TESTOSTERONE (TES), MODEL 30 418 |
Applicant |
BIOMERIEUX, INC. |
595 ANGLUM RD. |
HAZELWOOD,
MO
63042
|
|
Applicant Contact |
KELLY ROWLAND |
Correspondent |
BIOMERIEUX, INC. |
595 ANGLUM RD. |
HAZELWOOD,
MO
63042
|
|
Correspondent Contact |
KELLY ROWLAND |
Regulation Number | 862.1680
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/26/2002 |
Decision Date | 07/18/2002 |
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
|
Recalls |
CDRH Recalls
|
|
|