FDA 510(k) Applications for Medical Device Product Code: KLS (Enzyme Immunoassay, Theophylline)

FDA 510(k) Applications for Medical Device Product Code "KLS"
(Enzyme Immunoassay, Theophylline)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K013272	BAYER CORP.	ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY	10/25/2001
K961462	BOEHRINGER MANNHEIM CORP.	CEDIA THEOPHYLLINE ASSAY	06/27/1996
K972495	CHEMTRAK, INC.	ACCUMETER THEOPHYLLINE TEST	10/10/1997
K042407	DADE BEHRING, INC.	EMIT CAFFEINE ASSAY	10/28/2004
K042520	Ortho-Clinical Diagnostics, Inc.	VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III	11/30/2004
K011771	RANDOX LABORATORIES, LTD.	RANDOX THEOPHYLLINE	01/17/2002
K020740	ROCHE DIAGNOSTICS CORP.	ROCHE ONLINE THEOPHYLLINE	04/16/2002
K973583	SCHIAPPARELLI BIOSYSTEMS, INC.	ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS	11/12/1997
K993029	SYVA CO.	ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89	01/27/2000
K011166	SYVA CO., DADE BEHRING, INC.	MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229	05/10/2001