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510(k) K083846

Device
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
Applicant
LUMINEX MOLECULAR DIAGNOSTICS, INC.
510(k) number
K083846
Product code
NUA  
Decision
Substantially Equivalent (SESE)
Decision date
2009-09-01
Date received
2008-12-24
Regulation
866.5900
Classification name
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Medical specialty
Immunology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GLORIA LEE
Address
439 University Ave. Toronto, Ontario CA m5g 1y8 m5g 1y8

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NUA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRLuminex Molecular Diagnostics, Inc.2016-12-15
K163347xTAG Cystic Fibrosis 39 Kit v2Luminex Molecular Diagnostics, Inc.2016-12-15
K083845XTAG CF60 KIT V2Luminex Molecular Diagnostics, Inc.2009-12-11
K083294VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TESTNanosphere, Inc.2009-07-24
K090901ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8Osmetech Molecular Diagnostics2009-07-06
K063787INPLEX CF MOLECULAR TESTThird Wave Technologies, Inc.2008-03-13
K062028CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01Celera Diagnostics2007-09-07
K060627TAG-IT CYSTIC FIBROSIS KITTm Bioscience Corporation2006-06-07
K060543ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800Clinical Micro Sensors, Inc.2006-03-28
K051435ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800Clinical Micro Sensors2006-01-19
DEN050004TAG-IT CYSTIC FIBROSIS KITTm Bioscience Corporation2005-05-09

Legacy Summary#

summary

FDA Review#

Decision Summary