Source document or public record
FDA 510(k) K192920 — Oragene®Dx
FDA 510(k) index record K192920. Device: Oragene®Dx. Applicant as listed: DNA Genotek, Inc.. Decision date: 2020-01-14.
Source
"device_name": "Oragene®Dx"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K192920.
Device name: Oragene®Dx. Applicant as listed: DNA Genotek, Inc..
Decision date: 2020-01-14. Decision wording: Substantially Equivalent.
Product code: OYJ. Regulation: 21 CFR 862.1675. Medical specialty: Clinical Chemistry.
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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