510(k) K090901

Device: ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
Applicant: OSMETECH MOLECULAR DIAGNOSTICS
510(k) number: K090901
Product code: NUA
Decision: Substantially Equivalent (SESE)
Decision date: 2009-07-06
Date received: 2009-04-01
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#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K163336	xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR	Luminex Molecular Diagnostics, Inc.	2016-12-15
K163347	xTAG Cystic Fibrosis 39 Kit v2	Luminex Molecular Diagnostics, Inc.	2016-12-15
K083845	XTAG CF60 KIT V2	Luminex Molecular Diagnostics, Inc.	2009-12-11
K083846	XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267	Luminex Molecular Diagnostics, Inc.	2009-09-01
K083294	VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST	Nanosphere, Inc.	2009-07-24
K063787	INPLEX CF MOLECULAR TEST	Third Wave Technologies, Inc.	2008-03-13
K062028	CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01	Celera Diagnostics	2007-09-07
K060627	TAG-IT CYSTIC FIBROSIS KIT	Tm Bioscience Corporation	2006-06-07
K060543	ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800	Clinical Micro Sensors, Inc.	2006-03-28
K051435	ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800	Clinical Micro Sensors	2006-01-19
DEN050004	TAG-IT CYSTIC FIBROSIS KIT	Tm Bioscience Corporation	2005-05-09

summary

Decision Summary