510(k) K042520

Device: VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
Applicant: Ortho-Clinical Diagnostics, Inc.
510(k) number: K042520
Product code: KLS
Decision: Substantially Equivalent (SESE)
Decision date: 2004-11-30
Date received: 2004-09-16
Regulation: 862.3880
Classification name: Enzyme Immunoassay, Theophylline
Medical specialty: Toxicology
Review panel: Toxicology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K042407	EMIT CAFFEINE ASSAY	Dade Behring, Inc.	2004-10-28
K020740	ROCHE ONLINE THEOPHYLLINE	Roche Diagnostics Corp.	2002-04-16
K011771	RANDOX THEOPHYLLINE	Randox Laboratories, Ltd.	2002-01-17
K013272	ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY	Bayer Corp.	2001-10-25
K011166	MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229	Syva Co., Dade Behring, Inc.	2001-05-10
K993029	ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89	Syva Co.	2000-01-27
K973583	ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS	Schiapparelli Biosystems, Inc.	1997-11-12
K972495	ACCUMETER THEOPHYLLINE TEST	Chemtrak, Inc.	1997-10-10
K961462	CEDIA THEOPHYLLINE ASSAY	Boehringer Mannheim Corp.	1996-06-27
K954569	IMMULITE THEOPHYLLINE	Diagnostic Products Corp.	1995-11-13
K952596	THEOPHYLLINE ENZYME IMMUNOASSAY	Diagnostic Reagents, Inc.	1995-08-11
K943979	IL TEST THEOPHYLLINE	Instrumentation Laboratory CO	1995-01-18
K935373	AXSYM THEOPHYLLINE	Abbott Laboratories	1994-06-21
K932685	PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS	Baxter Diagnostics, Inc.	1993-09-24
K933258	VIDAS THEOPHYLLINE(THEO)	Biomerieux Vitek, Inc.	1993-08-16

summary

Decision Summary