Aca du Pont Methotrexate (Mtho) Method
FDA 510(k) K884744 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK884744
Submission
- Device name
- Aca du Pont Methotrexate (Mtho) Method
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- November 14, 1988
- Decision date
- January 30, 1989
- 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 |
| 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 |
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Questions and answers
When was Aca du Pont Methotrexate (Mtho) Method cleared by the FDA?
Aca du Pont Methotrexate (Mtho) Method (K884744) received a 510(k) decision of Substantially Equivalent on January 30, 1989, 77 days after the submission was received.
What is the product code of K884744?
The FDA product code is LAO – Enzyme Immunoassay, Methotrexate, a Unclassified device.