Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Ark Diagnostics with 16 510(k) clearances. The most recent is a 510(k) clearance dated Feb 27, 2024: ARK Levetiracetam II Assay.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Feb 27, 2024 | ARK Levetiracetam II AssayK232522 · ORI | 510(k) clearances |
| Dec 20, 2023 | ARK Methotrexate II AssayK232017 · LAO | 510(k) clearances |
| Nov 9, 2023 | ARK Hydrocodone AssayK231752 · DJG | 510(k) clearances |
| Aug 5, 2021 | ARK Lacosamide AssayK201089 · NWM | 510(k) clearances |
| Feb 26, 2020 | ARK Fentanyl II AssayK200197 · DJG | 510(k) clearances |
| Dec 10, 2018 | ARK Tramadol AssayK182280 · DJG | 510(k) clearances |
| Nov 21, 2018 | ARK EDDP AssayK182779 · DJR | 510(k) clearances |
| Jun 6, 2018 | ARK Fentanyl AssayK180427 · DJG | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
