510(k) Report

Devices descending from K080911

1 later device reach Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc.20170—