FDA.reportPublic FDA data

510(k) K070597

Device
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST
Applicant
NANOSPHERE, INC
510(k) number
K070597
Product code
NSU  
Decision
Substantially Equivalent (SESE)
Decision date
2007-10-11
Date received
2007-03-02
Regulation
862.2570
Classification name
Instrumentation For Clinical Multiplex Test Systems
Medical specialty
Clinical Chemistry
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SUE KENT
Address
4088 Commercial Ave. Northbrook IL US 60062 60062

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
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
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
DEN040012AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEMAffymetrix, Inc.2004-12-23

Legacy Summary#

summary

FDA Review#

Decision Summary