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KLR — Enzyme Immunoassay, Lidocaine Class II

FDA Device Classification

Classification Details

Product Code
KLR
Device Class
Class II
Regulation Number
862.3555
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K090282thermo fisher scientificQMS LIDOCAINEMay 29, 2009
K033809dade behringDIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRAFebruary 20, 2004
K032334roche diagnosticsROCHE ONLINE TDM LIDOCAINEJanuary 12, 2004
K973102diagnostic reagentsLIDOCAINE EIA ASSAYSeptember 12, 1997
K881116diagnostic systemsEASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641June 20, 1988
K853010roche diagnostic systemsCOBAS REAGENT FOR LIDOCAINE & CALIBRATORSAugust 7, 1985
K843184american dadeSTRATUS LIDOCAINE FLUOROMETRIC ENZYMESeptember 26, 1984
K833379e.i. dupont de nemours and coLIDOCAINE ANALYTICAL TEST PACK ACADecember 27, 1983
K833381e.i. dupont de nemours and coVALPROIC ACID ANALYTICAL TEST PACKDecember 27, 1983
K833623syvaMODIF. OF EMIT CAD DISOPYRAMIDE ASSAYDecember 8, 1983
K832799syvaMODIFICA- OF EMIT CAD LIDOCAINE ASSAYOctober 14, 1983
K831354syvaEMIT QST LIDOCAINE ASSAYMay 27, 1983
K823887syvaADVANCE EMIT CAD DISOPYRAMIDE ASSAYJanuary 28, 1983
K823866syvaADVANCE EMIT CAD LIDOCAINE ASSAYJanuary 12, 1983
K822347american diagnosticLIDOCAINE FLUORESCENT IMMUNOASSAYAugust 25, 1982
K802131abbott laboratoriesCYBREX LIDOCAINEOctober 31, 1980
K801204syvaEMIT DISOPYRAMIDE ASSAYJune 9, 1980