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FDA 510(k)

Oragene®•Dx

K-Number: K192920 · 2020-01-14

ApplicantDNA Genotek, Inc.
Decision Date2020-01-14
Product CodeOYJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Oragene®•Dx is a medical device manufactured by DNA Genotek, Inc.. It received FDA 510(k) clearance on 2020-01-14 under approval 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. It is manufactured by DNA Genotek, Inc.. The 510(k) number is K192920.

When was Oragene®•Dx approved by the FDA?

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

What company makes Oragene®•Dx?

Oragene®•Dx is manufactured by DNA Genotek, Inc..

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

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

Other Devices by DNA Genotek, Inc.

K152556Oragene Dx K152464ORAcollect.Dx DEN200040OMNIgene GUT Dx K212745ORAcollect®•Dx

Related Devices (Code: OYJ)

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

Official Source

View on FDA Database →

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

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