ESENSOR WARFARIN SENSITIVITY SALIVA TEST— 510(k) K110786

Name: FDA 510(k) clearance K110786
Creator: U.S. Food and Drug Administration
Published: 2011-12-02

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.. Device class: 2.

Clearance details

Applicant: GenMark Diagnostics, Inc.
Product code: Code NSU
Device class: Class 2
Regulation: 21 CFR 862.2570
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 ↗

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