510(k) Report

Devices descending from K051072

3 later devices reach Bio-Rad Variant NBS Sickle Cell Program through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080911Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and…Bio-Rad Laboratories Inc., Clinical Systems Divisi20081—
+1K050709Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367Wallac OY200601
+2K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc.20170—