FDA 510(k) Application Details - K020371

Device Classification Name	Enzyme Immunoassay, Opiates   More FDA Info for this Device
510(K) Number	K020371
Device Name	Enzyme Immunoassay, Opiates
Applicant	ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. BETHLEHEM, PA 18018-1799 US Other 510(k) Applications for this Company
Contact	R. SAM NIEDBALA Other 510(k) Applications for this Contact
Regulation Number	862.3650   More FDA Info for this Regulation Number
Classification Product Code	DJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2002
Decision Date	04/03/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review