510(k) K232017
- Device
- ARK Methotrexate II Assay
- Applicant
- Ark Diagnostics, Inc.
- 510(k) number
- K232017
- Product code
- LAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-20
- Date received
- 2023-07-07
- Classification name
- Enzyme Immunoassay, Methotrexate
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Thomas Houts
- Address
- 48089 Fremont Blvd. Fremont CA US 94538 94538
FDA Registration Numbers#
- 3005755244
- 9610126
- 2517506
- 2521625
Source Documents#
Other 510(k) Records For Product Code LAO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233454 | ONLINE TDM Methotrexate | Roche Diagnostics Operations | 2024-02-20 |
| 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 |