FDA 510(k) Application Details - K033809

Device Classification Name	Enzyme Immunoassay, Lidocaine   More FDA Info for this Device
510(K) Number	K033809
Device Name	Enzyme Immunoassay, Lidocaine
Applicant	DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.O. BOX 6101, NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	RICHARD M VAUGHT Other 510(k) Applications for this Contact
Regulation Number	862.3555   More FDA Info for this Regulation Number
Classification Product Code	KLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2003
Decision Date	02/20/2004
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