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LAO — Enzyme Immunoassay, Methotrexate Class U

FDA Device Classification

Classification Details

Product Code
LAO
Device Class
Class U
Regulation Number
Submission Type
Review Panel
TX
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233454roche diagnostics operationsONLINE TDM MethotrexateFebruary 20, 2024
K232017ark diagnosticsARK Methotrexate II AssayDecember 20, 2023
K163359ark diagnosticsARK Methotrexate AssayAugust 18, 2017
K111904ark diagnosticsARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, AOctober 18, 2011
K932615abbott laboratoriesTDX(R)/TDX(R)FLX(R)MEHTOTREXATE IIJuly 14, 1993
K884744e.i. dupont de nemours and coACA DU PONT METHOTREXATE (MTHO) METHODJanuary 30, 1989
K833634syvaEMIT & METHOFREXATE ASSAYDecember 22, 1983
K830398abbott laboratoriesTDX METHOTREXATEMarch 10, 1983
K811459syvaEMIT-AND METHOTREXATE ASSAYJune 9, 1981
K781381dade behringEMIT METHATREXATE ASSAYOctober 10, 1978