FDA 510(k)

Oragene Dx

K-Number: K152556 · 2016-05-26

Decision Date2016-05-26

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 2016-05-26 under 510(k) number K152556. 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 2016-05-26. The listed applicant is DNA Genotek, Inc.. The 510(k) number is K152556.

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

Oragene Dx received FDA 510(k) clearance on 2016-05-26, under 510(k) number K152556.

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 K192920Oragene®•Dx K152464ORAcollect.Dx

Related Devices (Code: OYJ)

K212745ORAcollect®•DxDNA Genotek, Inc.K192947AncestryDNA Saliva Collection KitAncestry Genomics, Inc.K192920Oragene®•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.