FDA 510(k)

Oragene®•Dx

K-Number: K192920 · 2020-01-14

Decision Date2020-01-14

Product CodeOYJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Oragene®•Dx is the device name listed in this FDA 510(k) record. The listed applicant is DNA Genotek, Inc.. It received FDA 510(k) clearance on 2020-01-14 under 510(k) number K192920. The device is classified under product code OYJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oragene®•Dx?

Oragene®•Dx is a medical device that received FDA 510(k) clearance on 2020-01-14. The listed applicant is DNA Genotek, Inc.. The 510(k) number is K192920.

When did Oragene®•Dx receive FDA 510(k) clearance?

Oragene®•Dx received FDA 510(k) clearance on 2020-01-14, under 510(k) number K192920.

Who is the listed applicant for Oragene®•Dx?

The FDA 510(k) record lists DNA Genotek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oragene®•Dx?

The FDA product code for Oragene®•Dx is OYJ.

Other records listing DNA Genotek, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254121Colli-Pee•Dx Urine Collection Kit K212745ORAcollect®•Dx K152556Oragene Dx K152464ORAcollect.Dx

Related Devices (Code: OYJ)

K212745ORAcollect®•DxDNA Genotek, Inc.K192947AncestryDNA Saliva Collection KitAncestry Genomics, Inc.K152556Oragene DxDNA Genotek, Inc.K152464ORAcollect.DxDNA Genotek, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.