ARK Methotrexate II Assay
FDA 510(k) clearance K232017 · decided 2023-12-20
Clearance details
- K-number
- K232017
- Device name
- ARK Methotrexate II Assay
- Applicant
- Ark Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-07
- Decision date
- 2023-12-20
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- LAO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ark Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ONLINE TDM Methotrexate (K233454) | Roche Diagnostics Operations | 2024-02-20 |
| ARK Methotrexate Assay (K163359) | Ark Diagnostics, Inc. | 2017-08-18 |
| ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN (K111904) | Ark Diagnostics, Inc. | 2011-10-18 |
| TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II (K932615) | Abbott Laboratories | 1993-07-14 |
| ACA DU PONT METHOTREXATE (MTHO) METHOD (K884744) | E.I. Dupont DE Nemours & Co., Inc. | 1989-01-30 |
| EMIT & METHOFREXATE ASSAY (K833634) | Syva Co. | 1983-12-22 |
| TDX METHOTREXATE (K830398) | Abbott Laboratories | 1983-03-10 |
| EMIT-AND METHOTREXATE ASSAY (K811459) | Syva Co. | 1981-06-09 |
| EMIT METHATREXATE ASSAY (K781381) | Dade Behring, Inc. | 1978-10-10 |
Recalls involving this device
No recalls on record reference this clearance.