FDA 510(k) Application Details - K160202

Device Classification Name	Radioimmunoassay, Vancomycin   More FDA Info for this Device
510(K) Number	K160202
Device Name	Radioimmunoassay, Vancomycin
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE, PO BOX 6101 MS 514 Newark, DE 19711 US Other 510(k) Applications for this Company
Contact	Laura J. Duggan 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	01/28/2016
Decision Date	04/27/2016
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