ESENSOR WARFARIN SENSITIVITY SALIVA TEST— 510(k) K110786

Substantially Equivalent

GenMark Diagnostics, Inc.

FDA 510(k) clearance K110786 for ESENSOR WARFARIN SENSITIVITY SALIVA TEST, Substantially Equivalent on 2011-12-02. Applicant: GenMark Diagnostics, Inc..

Clearance details

Applicant: GenMark Diagnostics, Inc.
Product code: Code NSU
Advisory panel: Clinical Chemistry
Date received: 2011-03-22
Decision date: 2011-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.