Device Classification Name |
radioimmunoassay, free thyroxine
|
510(k) Number |
K132058 |
Device Name |
VIDAS FT4 |
Applicant |
BIOMERIEUX SA |
5 RUE DES AQUEDUCS |
CRAPONNE,
FR
69290
|
|
Applicant Contact |
AURELIE PERMEZEL |
Correspondent |
BIOMERIEUX SA |
5 RUE DES AQUEDUCS |
CRAPONNE,
FR
69290
|
|
Correspondent Contact |
AURELIE PERMEZEL |
Regulation Number | 862.1695
|
Classification Product Code |
|
Date Received | 07/03/2013 |
Decision Date | 06/08/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|