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FDA 510(k)

ORAcollect.Dx

K-Number: K152464 · 2016-05-26

ApplicantDNA Genotek, Inc.
Decision Date2016-05-26
Product CodeOYJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ORAcollect.Dx is a medical device manufactured by DNA Genotek, Inc.. It received FDA 510(k) clearance on 2016-05-26 under approval number K152464. 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 ORAcollect.Dx?

ORAcollect.Dx is a medical device that received FDA 510(k) clearance on 2016-05-26. It is manufactured by DNA Genotek, Inc.. The 510(k) number is K152464.

When was ORAcollect.Dx approved by the FDA?

ORAcollect.Dx received FDA 510(k) clearance on 2016-05-26, under approval number K152464.

What company makes ORAcollect.Dx?

ORAcollect.Dx is manufactured by DNA Genotek, Inc..

What is the FDA product code for ORAcollect.Dx?

The FDA product code for ORAcollect.Dx is OYJ.

Other Devices by DNA Genotek, Inc.

K152556Oragene Dx K192920Oragene®•Dx DEN200040OMNIgene GUT Dx K212745ORAcollect®•Dx

Related Devices (Code: OYJ)

K152556Oragene DxDNA Genotek, Inc. K192947AncestryDNA Saliva Collection KitAncestry Genomics, Inc. K192920Oragene®•DxDNA Genotek, 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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