FDA 510(k) Application Details - K171695

Device Classification Name	Test, Amphetamine, Over The Counter   More FDA Info for this Device
510(K) Number	K171695
Device Name	Test, Amphetamine, Over The Counter
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	862.3100   More FDA Info for this Regulation Number
Classification Product Code	NFT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2017
Decision Date	02/05/2018
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