FDA 510(k) Application Details - K013882

Device Classification Name	Enzyme Immunoassay, Benzodiazipine   More FDA Info for this Device
510(K) Number	K013882
Device Name	Enzyme Immunoassay, Benzodiazipine
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	862.3170   More FDA Info for this Regulation Number
Classification Product Code	JXM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2001
Decision Date	04/17/2002
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