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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2016-05-26 under 510(k) 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. The listed applicant is Genmark Diagnostics, Incorporated. The 510(k) number is K152612.

When did eSensor Warfarin Sensitivity Saliva Test receive FDA 510(k) clearance?

eSensor Warfarin Sensitivity Saliva Test received FDA 510(k) clearance on 2016-05-26, under 510(k) number K152612.

Who is the listed applicant for eSensor Warfarin Sensitivity Saliva Test?

The FDA 510(k) record lists Genmark Diagnostics, Incorporated as the applicant. This does not by itself establish the device manufacturer.

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.

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