Oragene Dx— 510(k) K152556

Substantially Equivalent

DNA Genotek, Inc.

FDA 510(k) clearance K152556 for Oragene Dx, Substantially Equivalent on 2016-05-26. 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: 2015-09-08
Decision date: 2016-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code OYJ

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K192947 — AncestryDNA Saliva Collection Kit2020-08-13
K192920 — Oragene®Dx2020-01-14
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K141410 — ORAGENE DX OGD-500.0012015-02-19

More clearances from DNA Genotek, Inc.

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