Documento fuente o registro público

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.

OtherU.S. Food and Drug Administration (FDA)2020-01-14

Fuente

"device_name": "Oragene®Dx"
api.fda.gov · Consultado el 2026-10-19

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

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Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

References

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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FDA 510(k) K192920 — Oragene®Dx

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