510(k) Report

Devices descending from K083845

2 later devices reach Xtag CF60 Kit V2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K124006Illumina Miseqdx Cystic Fibrosis 139-Variant AssayIllumina, Inc.20130—
+1K132750Illumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayIllumina, Inc.201302