FDA 510(k) Application Details - K020740

Device Classification Name	Enzyme Immunoassay, Theophylline   More FDA Info for this Device
510(K) Number	K020740
Device Name	Enzyme Immunoassay, Theophylline
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	MIKE FLIS 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	03/06/2002
Decision Date	04/16/2002
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