ARK Methotrexate Assay
FDA 510(k) K163359 · Ark Diagnostics, Inc.
510(k) numberK163359
Submission
- Device name
- ARK Methotrexate Assay
- Applicant
- Ark Diagnostics, Inc.
Fremont, CA, US - Received
- November 30, 2016
- Decision date
- August 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232522 | ARK Levetiracetam II AssayORI · Traditional | 02/27/2024SE |
| K232017 | ARK Methotrexate II AssayLAO · Traditional | 12/20/2023SE |
| K231752 | ARK Hydrocodone AssayDJG · Traditional | 11/09/2023SE |
| K201089 | ARK Lacosamide AssayNWM · Traditional | 08/05/2021SE |
| K200197 | ARK Fentanyl II AssayDJG · Traditional | 02/26/2020SE |
| K182280 | ARK Tramadol AssayDJG · Traditional | 12/10/2018SE |
| K182779 | ARK EDDP AssayDJR · Traditional | 11/21/2018SE |
| K180427 | ARK Fentanyl AssayDJG · Traditional | 06/06/2018SE |
| K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK…POX · Traditional | 08/09/2016SE |
| K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark…LAO · Traditional | 10/18/2011SE |
Questions and answers
When was ARK Methotrexate Assay cleared by the FDA?
ARK Methotrexate Assay (K163359) received a 510(k) decision of Substantially Equivalent on August 18, 2017, 261 days after the submission was received.
What is the product code of K163359?
The FDA product code is LAO – Enzyme Immunoassay, Methotrexate, a Unclassified device.