LAO · Enzyme Immunoassay, Methotrexate
· Class U
Overview
| Product Code | LAO |
|---|---|
| Device Name | Enzyme Immunoassay, Methotrexate |
| Device Class | Class U |
| Review Panel |
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233454 | ONLINE TDM Methotrexate | Roche Diagnostics Operations | Feb 20, 2024 | SESE |
| K232017 | ARK Methotrexate II Assay | Ark Diagnostics, Inc. | Dec 20, 2023 | SESE |
| K163359 | ARK Methotrexate Assay | Ark Diagnostics, Inc. | Aug 18, 2017 | SESE |
| K111904 | ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN | Ark Diagnostics, Inc. | Oct 18, 2011 | SESE |
| K932615 | TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II | Abbott Laboratories | Jul 14, 1993 | SESE |
| K884744 | ACA DU PONT METHOTREXATE (MTHO) METHOD | E.I. Dupont DE Nemours & Co., Inc. | Jan 30, 1989 | SESE |
| K833634 | EMIT & METHOFREXATE ASSAY | Syva Co. | Dec 22, 1983 | SESE |
| K830398 | TDX METHOTREXATE | Abbott Laboratories | Mar 10, 1983 | SESE |
| K811459 | EMIT-AND METHOTREXATE ASSAY | Syva Co. | Jun 9, 1981 | SESE |
| K781381 | 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
