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510(k) K062028

Device
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01
Applicant
CELERA DIAGNOSTICS
510(k) number
K062028
Product code
NUA  
Decision
Substantially Equivalent (SESE)
Decision date
2007-09-07
Date received
2006-07-18
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
VICTORIA MACKINNON
Address
1401 Harbor Bay Pkwy. Alameda CA US 94502 94502

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
K083846XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267Luminex Molecular Diagnostics, Inc.2009-09-01
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
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