Product code LAO
- Device name
- Enzyme Immunoassay, Methotrexate
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233454 | ONLINE TDM Methotrexate | Roche Diagnostics Operations | 2024-02-20 |
| K232017 | ARK Methotrexate II Assay | Ark Diagnostics, Inc. | 2023-12-20 |
| K163359 | ARK Methotrexate Assay | Ark Diagnostics, Inc. | 2017-08-18 |
| K111904 | ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN | Ark Diagnostics, Inc. | 2011-10-18 |
| K932615 | TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II | Abbott Laboratories | 1993-07-14 |
| K884744 | ACA DU PONT METHOTREXATE (MTHO) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1989-01-30 |
| K833634 | EMIT & METHOFREXATE ASSAY | Syva Co. | 1983-12-22 |
| K830398 | TDX METHOTREXATE | Abbott Laboratories | 1983-03-10 |
| K811459 | EMIT-AND METHOTREXATE ASSAY | Syva Co. | 1981-06-09 |
| K781381 | EMIT METHATREXATE ASSAY | Dade Behring, Inc. | 1978-10-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812101031179 | ARK™ Methotrexate II Assay | ARK DIAGNOSTICS INC | 2024-10-24 |
| 00812101031186 | ARK™ Methotrexate II Calibrator | ARK DIAGNOSTICS INC | 2024-10-24 |
| 00812101031193 | ARK™ Methotrexate II Control | ARK DIAGNOSTICS INC | 2024-10-24 |
| 00812101031209 | ARK™ Methotrexate II Control | ARK DIAGNOSTICS INC | 2024-10-24 |
| 00812101031216 | ARK™ Methotrexate II Control | ARK DIAGNOSTICS INC | 2024-10-24 |
| 00812101031223 | ARK™ Methotrexate II Dilution Buffer | ARK DIAGNOSTICS INC | 2024-10-24 |
| 00812101031162 | ARK™ Methotrexate II Assay | ARK DIAGNOSTICS INC | 2024-10-24 |
| 07613336224823 | ONLINE TDM Methotrexate | Roche Diagnostics GmbH | 2024-03-25 |
| 07613336224816 | ONLINE TDM Methotrexate | Roche Diagnostics GmbH | 2024-03-25 |
| 00812101030639 | ARK™ Methotrexate Assay | ARK DIAGNOSTICS INC | 2020-08-31 |
| 00842768001383 | Syva® Emit® Methotrexate Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00858724003056 | ARK™ Methotrexate Assay | ARK DIAGNOSTICS INC | 2016-09-24 |
| 00858724003216 | ARK™ Methotrexate Assay (c-pack) | ARK DIAGNOSTICS INC | 2016-09-24 |
| 00858724003254 | ARK™ Methotrexate Assay | ARK DIAGNOSTICS INC | 2016-09-24 |
| 00380740011611 | ABBOTT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740011628 | ABBOTT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740011635 | ABBOTT | ABBOTT LABORATORIES | 2016-09-09 |