FDA 510(k) Application Details - K132058

Device Classification Name	Radioimmunoassay, Free Thyroxine   More FDA Info for this Device
510(K) Number	K132058
Device Name	Radioimmunoassay, Free Thyroxine
Applicant	BIOMERIEUX SA 5 RUE DES AQUEDUCS CRAPONNE 69290 FR Other 510(k) Applications for this Company
Contact	AURELIE PERMEZEL Other 510(k) Applications for this Contact
Regulation Number	862.1695   More FDA Info for this Regulation Number
Classification Product Code	CEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2013
Decision Date	06/08/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review