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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number862.1695
Classification Product Code
CEC  
Date Received07/03/2013
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
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