FDA 510(k) Application Details - K171403

Device Classification Name	Thin Layer Chromatography, Metamphetamine   More FDA Info for this Device
510(K) Number	K171403
Device Name	Thin Layer Chromatography, Metamphetamine
Applicant	Premier Biotech Inc 723 Kasota Avenue SE Minneapolis, MN 55414 US Other 510(k) Applications for this Company
Contact	Jacqueline Gale Other 510(k) Applications for this Contact
Regulation Number	862.3610   More FDA Info for this Regulation Number
Classification Product Code	DJC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2017
Decision Date	02/02/2018
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