Source document or public record
FDA 510(k) K231752 — ARK Hydrocodone Assay
FDA 510(k) index record K231752. Device: ARK Hydrocodone Assay. Applicant as listed: Ark Diagnostics, Inc.. Decision date: 2023-11-09.
Source
"device_name": "ARK Hydrocodone Assay"
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2026-10-20
2026-10-20
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FDA 510(k) public index record K231752.
Device name: ARK Hydrocodone Assay. Applicant as listed: Ark Diagnostics, Inc..
Decision date: 2023-11-09. Decision wording: Substantially Equivalent.
Product code: DJG. Regulation: 21 CFR 862.3650. 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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