Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- DEPLambda, Peroxidase, Antigen, Antiserum, Control2Product Code
- DEYIgm, Peroxidase, Antigen, Antiserum, Control2Product Code
- DFDKappa, Peroxidase, Antigen, Antiserum, Control2Product Code
- DGHIgd, Peroxidase, Antigen, Antiserum, Control2Product Code
- DAAIgg, Peroxidase, Antigen, Antiserum, Control2Product Code
- DGOIge, Peroxidase, Antigen, Antiserum, Control2Product Code
- DHFD/Km-1, Antigen, Antiserum, Control1Product Code
- LYECytokeratins2Product Code
- NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection2Product Code
- K163347xTAG Cystic Fibrosis 39 Kit v22Cleared 510(K)
- K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR2Cleared 510(K)
- K083845XTAG CF60 KIT V22Cleared 510(K)
- K083846XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E02672Cleared 510(K)
- K083294VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST2Cleared 510(K)
- K090901ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-82Cleared 510(K)
- K063787INPLEX CF MOLECULAR TEST2Cleared 510(K)
- K062028CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-012Cleared 510(K)
- K060627TAG-IT CYSTIC FIBROSIS KIT2Cleared 510(K)
- K060543ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 48002Cleared 510(K)
Show All 12 Submissions
- PFRSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection2Product Code
- PFSSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection2Product Code
- PFXSystem, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection2Product Code
- PKBAutosomal Recessive Carrier Screening Gene Mutation Detection System2Product Code
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
- Page Type
- Cleared 510(K)
- 510(k) Number
- K163336
- 510(k) Type
- Special
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Country
- Canada
- FDA Decision
- Substantially Equivalent - Kit
- Decision Date
- 12/15/2016
- Days to Decision
- 17 days
- Submission Type
- Statement