FDA 510(k) Application Details - K073078

Device Classification Name	High Pressure Liquid Chromatography, Methamphetamine   More FDA Info for this Device
510(K) Number	K073078
Device Name	High Pressure Liquid Chromatography, Methamphetamine
Applicant	AMERICAN BIO MEDICA CORP. 603 HERON DR. UNIT 3 LOGAN TOWNSHIP, NJ 08085 US Other 510(k) Applications for this Company
Contact	RICH REILLY Other 510(k) Applications for this Contact
Regulation Number	862.3610   More FDA Info for this Regulation Number
Classification Product Code	LAG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2007
Decision Date	05/30/2008
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