K233454
- 510(k) number
- K233454
- Device name
- ONLINE TDM Methotrexate
- Applicant
- Roche Diagnostics Operations IN · US
- Product code
- LAO — Enzyme Immunoassay, Methotrexate
- Decision date
- 2024-02-20
- Date received
- 2023-10-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233454.pdf
Official FDA record: K233454
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.