510(k) Report

Devices descending from K010748

4 later devices reach Synchron Systems Hemoglobin A1C Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120199Glycosylated Hemoglobin Assay; Clinical ChemistryBeckman Coulter, Inc.20120—
+1K121492Unicel DXC Synchron Systems Hemoglobin Alc-(HBA1C-) ReagentBeckman Coulter, Inc.20121—
+1K042459Synchron LX Systems Hemoglobin A1C2 (HBA1C2) ReagentBeckman Coulter, Inc.20040—
+2K140829Unicel DXC Synchron Systems Hemoglobin A1C3 (HBA1C3) ReagentBeckman Coulter, Inc.20140—