FDA 510(k) Application Details - K973784

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K973784
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	BIOSITE INCORPORATED 11030 ROSELLE ST. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	JOHN F BRUNI 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	10/03/1997
Decision Date	12/03/1997
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