FDA.reportPublic FDA data

510(k) K935373

Device
Axsym Theophylline
Applicant
ABBOTT LABORATORIES
510(k) number
K935373
Product code
KLS
Decision
Substantially Equivalent (SESE)
Decision date
1994-06-21
Date received
1993-11-08
Regulation
862.3880
Classification name
Enzyme Immunoassay, Theophylline
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KATHY ZENG
Address
Dept: 09v8 Bldg: Ap5-2 100 Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KLS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.2004-11-30
K042407EMIT CAFFEINE ASSAYDade Behring, Inc.2004-10-28
K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.2002-04-16
K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.2002-01-17
K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.2001-10-25
K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, Inc.2001-05-10
K993029ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89Syva Co.2000-01-27
K973583ACE THEOPHYLLINE REAGENT, THEO CALIBRATORSSchiapparelli Biosystems, Inc.1997-11-12
K972495ACCUMETER THEOPHYLLINE TESTChemtrak, Inc.1997-10-10
K961462CEDIA THEOPHYLLINE ASSAYBoehringer Mannheim Corp.1996-06-27
K954569IMMULITE THEOPHYLLINEDiagnostic Products Corp.1995-11-13
K952596THEOPHYLLINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.1995-08-11
K943979IL TEST THEOPHYLLINEInstrumentation Laboratory CO1995-01-18
K932685PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORSBaxter Diagnostics, Inc.1993-09-24
K933258VIDAS THEOPHYLLINE(THEO)Biomerieux Vitek, Inc.1993-08-16