FDA 510(k) Application Details - K033566

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K033566
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	RAPID DIAGNOSTICS, INC. 9418 LASAINE AVE. NORTHRIDGE, CA 91325 US Other 510(k) Applications for this Company
Contact	ROBIN J HELLEN Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	DKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2003
Decision Date	05/17/2004
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