FDA 510(k) Application Details - K152185

Device Classification Name	Radioimmunoassay, Testosterones And Dihydrotestosterone   More FDA Info for this Device
510(K) Number	K152185
Device Name	Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant	BIOKIT, S.A. CAN MALE, S/N LLICA D AMUNT 08186 ES Other 510(k) Applications for this Company
Contact	ANGELS ROMA Other 510(k) Applications for this Contact
Regulation Number	862.1680   More FDA Info for this Regulation Number
Classification Product Code	CDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2015
Decision Date	02/11/2016
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