510(k) Report

Devices descending from K031043

2 later devices reach D-10 Hemoglobin A1C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090737Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection…Bio-Rad Laboratories, Inc.20090—
+1K060001D-10 Hemoglobin A1C Program; D-10 Dual ProgramBio-Rad Laboratories, Inc.200601