K232522
- 510(k) number
- K232522
- Device name
- ARK Levetiracetam II Assay
- Applicant
- Ark Diagnostics, Inc. CA · US
- Product code
- ORI — Levetiracetam Assay
- Decision date
- 2024-02-27
- Date received
- 2023-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232522.pdf
Official FDA record: K232522
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.