FDA.reportPublic FDA data

510(k) K163652

Device
EPlex Instrument
Applicant
GenMark Diagnostics, Incorporated
510(k) number
K163652
Product code
NSU  
Decision
Substantially Equivalent (SESE)
Decision date
2017-06-09
Date received
2016-12-23
Regulation
862.2570
Classification name
Instrumentation For Clinical Multiplex Test Systems
Medical specialty
Clinical Chemistry
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alan Maderazo
Address
5964 La Pl. Ct. Carlsbad CA US 92008 92008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NSU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143178FilmArray 2.0 SystemBiofire Diagnostics, LLC2015-01-30
K133849VANTERA CLINICAL ANALYZERLiposcience2014-10-22
K141220APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWAREThermo Fisher Scientific (Life Technologies Holdin2014-05-22
K133302FLEXMAP 3DLuminex Corp.2014-01-10
K121399LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD PLuminex Corp.2013-01-09
K110786ESENSOR WARFARIN SENSITIVITY SALIVA TESTGenMark Diagnostics, Inc.2011-12-02
K093128ILLUMINA BEADXPRESS SYSTEMIllumina, Inc.2010-04-28
K082562APPLIED BIOSYSTEMS 7500 FAST DXApplied Biosystems, Inc.2008-09-30
K080995MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEMAffymetrix, Inc.2008-07-30
K073506LUMINEX LX 100/200 INSTRUMENTLuminex Corp.2008-03-07
K070597VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TESTNanosphere, Inc.2007-10-11
DEN040012AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEMAffymetrix, Inc.2004-12-23

Legacy Summary#

summary

FDA Review#

Decision Summary