eSensor Warfarin Sensitivity Saliva Test— 510(k) K152612
Substantially EquivalentGenmark Diagnostics, Incorporated
FDA 510(k) clearance K152612 for eSensor Warfarin Sensitivity Saliva Test, Substantially Equivalent on 2016-05-26. Applicant: Genmark Diagnostics, Incorporated. Device class: 2.
Clearance details
- Applicant
- Genmark Diagnostics, Incorporated
- Product code
- Code ODW
- Device class
- Class 2
- Regulation
- 21 CFR 862.3360
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
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