Oragene®Dx— 510(k) K192920

Substantially Equivalent

DNA Genotek, Inc.

FDA 510(k) clearance K192920 for Oragene®Dx, Substantially Equivalent on 2020-01-14. Applicant: DNA Genotek, Inc.. Device class: 2.

Clearance details

Applicant: DNA Genotek, Inc.
Product code: Code OYJ
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 2019-10-16
Decision date: 2020-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code OYJ

K212745 — ORAcollect®Dx2022-10-27
K192947 — AncestryDNA Saliva Collection Kit2020-08-13
K152464 — ORAcollect.Dx2016-05-26
K152556 — Oragene Dx2016-05-26
K141410 — ORAGENE DX OGD-500.0012015-02-19

More clearances from DNA Genotek, Inc.

K254121 — Colli-PeeDx Urine Collection Kit2026-06-10
DEN200040 — OMNIgene GUT Dx2021-11-03
K110701 — ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-5002011-12-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.