510(k) K110786

ESENSOR WARFARIN SENSITIVITY SALIVA TEST by GenMark Diagnostics, Inc. — Product Code NSU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 2, 2011
Date Received: March 22, 2011
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Instrumentation For Clinical Multiplex Test Systems
Device Class: Class II
Regulation Number: 862.2570
Review Panel: CH
Submission Type

Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de

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