510(k) Report

Devices descending from K060627

4 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—
+2K124006Illumina Miseqdx Cystic Fibrosis 139-Variant AssayIllumina, Inc.20130—
+2K132750Illumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayIllumina, Inc.201302