K232017
- 510(k) number
- K232017
- Device name
- ARK Methotrexate II Assay
- Applicant
- Ark Diagnostics, Inc. CA · US
- Product code
- LAO — Enzyme Immunoassay, Methotrexate
- Decision date
- 2023-12-20
- Date received
- 2023-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232017.pdf
Official FDA record: K232017
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.