FDA 510(k) Application Details - K170222

Device Classification Name	Gas Chromatography, Methamphetamine   More FDA Info for this Device
510(K) Number	K170222
Device Name	Gas Chromatography, Methamphetamine
Applicant	AMERICAN BIO MEDICA CORP. 122 SMITH ROAD KINDERHOOK, NY 12106 US Other 510(k) Applications for this Company
Contact	MELISSA WATERHOUSE 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	01/25/2017
Decision Date	08/15/2017
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