510(k) Report

Devices descending from K071466

8 later devices reach Dca Vantage, Model 5075 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163633cobas HbA1c Test, cobas b 101 systemRoche Diagnostics Operations20170—
+1K142664URight Hemoglobin A1c system, FORA A1c SystemTaidoc Technology Corporation20160—
+1K130014A1C Gear SystemSakae Corporation20141—
+1K082275Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023Infopia Co, Ltd.20102—
+1K091711S- Test Hemoglobin Alc (HBA1C), Model RC0023Alfa Wassermann Diagnostic Technologies, Inc.20090—
+2K142789A1c iGear SystemSakae Corporation20140—
+2K121366Hemocue HBA1C 501Infopia Co, Ltd.20121—
+3K141750Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring SystemInfopia Co, Ltd.20140—