FDA 510(k) Application Details - K983189

Device Classification Name	Gas Chromatography, Methamphetamine   More FDA Info for this Device
510(K) Number	K983189
Device Name	Gas Chromatography, Methamphetamine
Applicant	AMERITEK, INC. 7030 35TH AVE., N.E. SEATTLE, WA 98115 US Other 510(k) Applications for this Company
Contact	K C YEE 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	09/11/1998
Decision Date	11/18/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review