FDA 510(k) Application Details - K201442

Device Classification Name	Gas Chromatography, Methamphetamine   More FDA Info for this Device
510(K) Number	K201442
Device Name	Gas Chromatography, Methamphetamine
Applicant	Diatron Group 12601 N.W. 115th Avenue, Suite A113 Medley, FL 33178 US Other 510(k) Applications for this Company
Contact	Frank Matuszak 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	06/01/2020
Decision Date	07/31/2020
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