FDA 510(k) Application Details - K151441

Device Classification Name	Enzyme Immunoassay, Methadone   More FDA Info for this Device
510(K) Number	K151441
Device Name	Enzyme Immunoassay, Methadone
Applicant	W.H.P.M., INC. 5358 IRWINDALE AVE. IRWINDALE, CA 91706 US Other 510(k) Applications for this Company
Contact	JOHN WAN Other 510(k) Applications for this Contact
Regulation Number	862.3620   More FDA Info for this Regulation Number
Classification Product Code	DJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/2015
Decision Date	06/29/2015
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