# LAO · Enzyme Immunoassay, Methotrexate

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/LAO

## Overview

- **Product Code:** LAO
- **Device Name:** Enzyme Immunoassay, Methotrexate
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K233454](/device/K233454.md) | ONLINE TDM Methotrexate | Roche Diagnostics Operations | Feb 20, 2024 | SESE |
| [K232017](/device/K232017.md) | ARK Methotrexate II Assay | Ark Diagnostics, Inc. | Dec 20, 2023 | SESE |
| [K163359](/device/K163359.md) | ARK Methotrexate Assay | Ark Diagnostics, Inc. | Aug 18, 2017 | SESE |
| [K111904](/device/K111904.md) | ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN | Ark Diagnostics, Inc. | Oct 18, 2011 | SESE |
| [K932615](/device/K932615.md) | TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II | Abbott Laboratories | Jul 14, 1993 | SESE |
| [K884744](/device/K884744.md) | ACA DU PONT METHOTREXATE (MTHO) METHOD | E.I. Dupont DE Nemours & Co., Inc. | Jan 30, 1989 | SESE |
| [K833634](/device/K833634.md) | EMIT & METHOFREXATE ASSAY | Syva Co. | Dec 22, 1983 | SESE |
| [K830398](/device/K830398.md) | TDX METHOTREXATE | Abbott Laboratories | Mar 10, 1983 | SESE |
| [K811459](/device/K811459.md) | EMIT-AND METHOTREXATE ASSAY | Syva Co. | Jun 9, 1981 | SESE |
| [K781381](/device/K781381.md) | EMIT METHATREXATE ASSAY | Dade Behring, Inc. | Oct 10, 1978 | SESE |

## Top Applicants

- Ark Diagnostics, Inc. — 3 clearances
- Abbott Laboratories — 2 clearances
- Syva Co. — 2 clearances
- Dade Behring, Inc. — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/LAO](https://fda.innolitics.com/productcode/LAO)

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