Enzyme Immunoassay, Methotrexate
FDA product code LAO · Unclassified · Clinical Toxicology
10510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233454 | ONLINE TDM MethotrexateLAO · Traditional | Roche Diagnostics Operations | 02/20/2024SE |
| K232017 | ARK Methotrexate II AssayLAO · Traditional | Ark Diagnostics, Inc. | 12/20/2023SE |
| K163359 | ARK Methotrexate AssayLAO · Special | Ark Diagnostics, Inc. | 08/18/2017SE |
| K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark…LAO · Traditional | Ark Diagnostics, Inc. | 10/18/2011SE |
| K932615 | Tdx(R)/Tdx(R)Flx(R)Mehtotrexate IILAO · Traditional | Abbott Laboratories | 07/14/1993SE |
| K884744 | Aca du Pont Methotrexate (Mtho) MethodLAO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/30/1989SE |
| K833634 | Emit & Methofrexate AssayLAO · Traditional | Syva Co. | 12/22/1983SE |
| K830398 | TDX MethotrexateLAO · Traditional | Abbott Laboratories | 03/10/1983SE |
| K811459 | Emit-And Methotrexate AssayLAO · Traditional | Syva Co. | 06/09/1981SE |
| K781381 | Emit Methatrexate AssayLAO · Traditional | Dade Behring, Inc. | 10/10/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1618-2016 Class II | Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in…Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension… | Siemens Healthcare Diagnostics, Inc. | 03/08/2016Terminated |
| Z-1056-2007 | TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro…Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order… | Abbott Diagnostic International, Ltd. | 03/20/2007Terminated |