FDA 510(k) Application Details - K163220

Device Classification Name	Enzyme Immunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K163220
Device Name	Enzyme Immunoassay, Phencyclidine
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	862.3100   More FDA Info for this Regulation Number
Classification Product Code	LCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2016
Decision Date	04/06/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review