Oragene Dx
K-Number: K152556 · 2016-05-26
ApplicantDNA Genotek, Inc.
Decision Date2016-05-26
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 2016-05-26 under approval 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. It is manufactured by DNA Genotek, Inc.. The 510(k) number is K152556.
When was Oragene Dx approved by the FDA?
Oragene Dx received FDA 510(k) clearance on 2016-05-26, under approval number K152556.
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.
Related Devices (Code: OYJ)
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.