eSensor Warfarin Sensitivity Saliva Test
K-Number: K152612 · 2016-05-26
ApplicantGenmark Diagnostics, Incorporated
Decision Date2016-05-26
Product CodeODW
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
eSensor Warfarin Sensitivity Saliva Test is a medical device manufactured by Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2016-05-26 under approval number K152612. The device is classified under product code ODW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the eSensor Warfarin Sensitivity Saliva Test?
eSensor Warfarin Sensitivity Saliva Test is a medical device that received FDA 510(k) clearance on 2016-05-26. It is manufactured by Genmark Diagnostics, Incorporated. The 510(k) number is K152612.
When was eSensor Warfarin Sensitivity Saliva Test approved by the FDA?
eSensor Warfarin Sensitivity Saliva Test received FDA 510(k) clearance on 2016-05-26, under approval number K152612.
What company makes eSensor Warfarin Sensitivity Saliva Test?
eSensor Warfarin Sensitivity Saliva Test is manufactured by Genmark Diagnostics, Incorporated.
What is the FDA product code for eSensor Warfarin Sensitivity Saliva Test?
The FDA product code for eSensor Warfarin Sensitivity Saliva Test is ODW.
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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.