FDA 510(k) Application Details - K152245

Device Classification Name	Radioimmunoassay, Vancomycin   More FDA Info for this Device
510(K) Number	K152245
Device Name	Radioimmunoassay, Vancomycin
Applicant	ROCHE DIAGNOSTICS OPERATIONS (RDO) 9115 HAGUE ROAD INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	BARBARA MCWHORTER 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	08/10/2015
Decision Date	01/08/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review