510(k) Report

Devices descending from DEN050004

11 later devices reach Tag-IT Cystic Fibrosis Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083845Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc.20092—
+1K083846Xtag Cystic Fibrosis 39 Kit V2, (CFTR 39 Kit V2), Model I027C0231, I027D0266, I027E0267Luminex Molecular Diagnostics, Inc.20090—
+1K063787Inplex CF Molecular TestThird Wave Technologies, Inc.200821
+1K062028Cystic Fibrosis Genotyping Assay, Model 6L20-01Celera Diagnostics20070—
+1K060627Tag-IT Cystic Fibrosis KitTm Bioscience Corporation20064—
+1K051435Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System…Clinical Micro Sensors20063—
+2K124006Illumina Miseqdx Cystic Fibrosis 139-Variant AssayIllumina, Inc.20130—
+2K132750Illumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayIllumina, Inc.201302
+2K090901Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test…Osmetech Molecular Diagnostics200912
+2K060543Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc.20062—
+3K093974Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii GenotypingOsmetech Molecular Diagnostics20100—