FDA 510(k) Application Details - K123947

Device Classification Name	Radioimmunoassay, Vancomycin   More FDA Info for this Device
510(K) Number	K123947
Device Name	Radioimmunoassay, Vancomycin
Applicant	BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA 08186 ES Other 510(k) Applications for this Company
Contact	GUILLEM ANGLERILL Other 510(k) Applications for this Contact
Regulation Number	862.3950   More FDA Info for this Regulation Number
Classification Product Code	LEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2012
Decision Date	08/29/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review