FDA 510(k) Application Details - K133047

Device Classification Name	Gas Chromatography, Methamphetamine   More FDA Info for this Device
510(K) Number	K133047
Device Name	Gas Chromatography, Methamphetamine
Applicant	BIOPHOR DIAGNOSTICS, INC. 1201 DOUGLAS AVE REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	Nathaniel G Butlin Other 510(k) Applications for this Contact
Regulation Number	862.3610   More FDA Info for this Regulation Number
Classification Product Code	LAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2013
Decision Date	12/18/2014
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