FDA.reportPublic FDA data

510(k) K121399

Device
LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
Applicant
LUMINEX CORP.
510(k) number
K121399
Product code
NSU  
Decision
Substantially Equivalent (SESE)
Decision date
2013-01-09
Date received
2012-05-09
Regulation
862.2570
Classification name
Instrumentation For Clinical Multiplex Test Systems
Medical specialty
Clinical Chemistry
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Oliver Meek
Address
12212 Technology Blvd. Austin TX US 78727 78727

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NSU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K163652ePlex InstrumentGenmark Diagnostics, Incorporated2017-06-09
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
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#

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FDA Review#

Decision Summary