FDA 510(k) Application Details - K022915

Device Classification Name	Enzyme Immunoassay, Propoxyphene   More FDA Info for this Device
510(K) Number	K022915
Device Name	Enzyme Immunoassay, Propoxyphene
Applicant	ALFA SCIENTIFIC DESIGNS, INC. 12330 STOWE DR. POWAY, CA 92064 US Other 510(k) Applications for this Company
Contact	NAISHU WANG Other 510(k) Applications for this Contact
Regulation Number	862.3700   More FDA Info for this Regulation Number
Classification Product Code	JXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2002
Decision Date	11/29/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review