Documento fuente o registro público
FDA 510(k) K232522 — ARK Levetiracetam II Assay
FDA 510(k) index record K232522. Device: ARK Levetiracetam II Assay. Applicant as listed: Ark Diagnostics, Inc.. Decision date: 2024-02-27.
Fuente
"device_name": "ARK Levetiracetam II Assay"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-27
professional use
FDA 510(k) public index record K232522.
Device name: ARK Levetiracetam II Assay. Applicant as listed: Ark Diagnostics, Inc..
Decision date: 2024-02-27. Decision wording: Substantially Equivalent.
Product code: ORI. Regulation: 21 CFR 862.3350. Medical specialty: Clinical Toxicology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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