FDA 510(k) Application Details - K972481

Device Classification Name	Enzyme Immunoassasy, Nocotine And Nicotine Metabolites   More FDA Info for this Device
510(K) Number	K972481
Device Name	Enzyme Immunoassasy, Nocotine And Nicotine Metabolites
Applicant	ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. BETHLEHEM, PA 18018-1799 US Other 510(k) Applications for this Company
Contact	SAM R NIEDBALA Other 510(k) Applications for this Contact
Regulation Number	862.3220   More FDA Info for this Regulation Number
Classification Product Code	MKU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/1997
Decision Date	10/21/1997
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