TDX Methotrexate
FDA 510(k) K830398 · Abbott Laboratories
510(k) numberK830398
Submission
- Device name
- TDX Methotrexate
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- February 7, 1983
- Decision date
- March 10, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LAO – Enzyme Immunoassay, Methotrexate
- Device class
- Unclassified
Other 510(k)s with product code LAO
| 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 |
| K811459 | Emit-And Methotrexate AssayLAO · Traditional | Syva Co. | 06/09/1981SE |
| K781381 | Emit Methatrexate AssayLAO · Traditional | Dade Behring, Inc. | 10/10/1978SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252424 | Anti-HCV NextMZO · Traditional | 04/28/2026SE |
| K243500 | ARCHITECT iGentamicinLCD · Special | 07/09/2025SE |
| K243168 | Alinity i Rubella IgGLFX · Traditional | 06/20/2025SE |
| K243283 | Alinity h-series SystemGKZ · Traditional | 02/20/2025SE |
| K233932 | Alinity i Toxo IgMLGD · Traditional | 08/30/2024SE |
| K232669 | TbiQAT · Special | 09/29/2023SE |
| K222850 | HAVAb IgG IILOL · Traditional | 08/10/2023SE |
| K220031 | Alinity h-series SystemGKZ · Traditional | 08/04/2023SE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional | 07/14/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | 06/05/2023SE |
Questions and answers
When was TDX Methotrexate cleared by the FDA?
TDX Methotrexate (K830398) received a 510(k) decision of Substantially Equivalent on March 10, 1983, 31 days after the submission was received.
What is the product code of K830398?
The FDA product code is LAO – Enzyme Immunoassay, Methotrexate, a Unclassified device.