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KLS — Enzyme Immunoassay, Theophylline Class II

FDA Device Classification

Classification Details

Product Code
KLS
Device Class
Class II
Regulation Number
862.3880
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K042520ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II November 30, 2004
K042407dade behringEMIT CAFFEINE ASSAYOctober 28, 2004
K020740roche diagnosticsROCHE ONLINE THEOPHYLLINEApril 16, 2002
K011771randox laboratoriesRANDOX THEOPHYLLINEJanuary 17, 2002
K013272bayerACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYOctober 25, 2001
K011166syva co., dade behringMODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229May 10, 2001
K993029syvaABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89January 27, 2000
K973583schiapparelli biosystemsACE THEOPHYLLINE REAGENT, THEO CALIBRATORSNovember 12, 1997
K972495chemtrakACCUMETER THEOPHYLLINE TESTOctober 10, 1997
K961462boehringer mannheimCEDIA THEOPHYLLINE ASSAYJune 27, 1996
K954569diagnostic productsIMMULITE THEOPHYLLINENovember 13, 1995
K952596diagnostic reagentsTHEOPHYLLINE ENZYME IMMUNOASSAYAugust 11, 1995
K943979instrumentation laboratoryIL TEST THEOPHYLLINEJanuary 18, 1995
K935373abbott laboratoriesAXSYM THEOPHYLLINEJune 21, 1994
K932685baxter diagnosticsPARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORSSeptember 24, 1993
K933258biomerieux vitekVIDAS THEOPHYLLINE(THEO)August 16, 1993
K926245abbott laboratoriesABBOTT VISION THEOPHYLLINE IIAMay 6, 1993
K913123syvaEMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORSSeptember 19, 1991
K911060immunomatrixIMMUNOMATRIX THEOPHYLINE ASSAY SYSTEMMay 8, 1991
K910697instrumentation laboratoryIL THEOPHYLLINE ASSAY SYSTEMApril 3, 1991