FDA 510(k) Application Details - K970579

Device Classification Name	Thin Layer Chromatography, Morphine   More FDA Info for this Device
510(K) Number	K970579
Device Name	Thin Layer Chromatography, Morphine
Applicant	TECO DIAGNOSTICS 4925 EAST HUNTER AVE. ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	ANDREW REAMS Other 510(k) Applications for this Contact
Regulation Number	862.3640   More FDA Info for this Regulation Number
Classification Product Code	DNK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/1997
Decision Date	07/03/1997
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