FDA 510(k) Application Details - K012257

Device Classification Name	Enzyme Immunoassay, Amphetamine   More FDA Info for this Device
510(K) Number	K012257
Device Name	Enzyme Immunoassay, Amphetamine
Applicant	SYVA CO. 20400 MARIANI AVE. CUPERTINO, CA 95014 US Other 510(k) Applications for this Company
Contact	SUSAN L COLLINS 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	07/18/2001
Decision Date	08/03/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review