FDA 510(k) Application Details - K042407

Device Classification Name	Enzyme Immunoassay, Theophylline   More FDA Info for this Device
510(K) Number	K042407
Device Name	Enzyme Immunoassay, Theophylline
Applicant	DADE BEHRING, INC. P.O. BOX 6101 M/S 514 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	YUK-TING LEWIS Other 510(k) Applications for this Contact
Regulation Number	862.3880   More FDA Info for this Regulation Number
Classification Product Code	KLS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2004
Decision Date	10/28/2004
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