FDA 510(k) Application Details - K053032

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K053032
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	ACRO BIOTECH LLC. 9500 7TH STREET UNIT M RANCHO CUCAMONGA, CA 91730-9094 US Other 510(k) Applications for this Company
Contact	GREGORY LEE 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	10/27/2005
Decision Date	02/09/2006
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