510(k) Report

Devices descending from K963142

15 later devices reach Dca 2000 + Microalbumin/Creatinine Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072409Afinion Acr and Acr ControlAxis-Shield Poc AS20085—
+1K071466Dca Vantage, Model 5075Siemens Medical Solutions Diagnostics200781
+2K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation20241—
+2K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics201722
+2K163633cobas HbA1c Test, cobas b 101 systemRoche Diagnostics Operations20170—
+2K142664URight Hemoglobin A1c system, FORA A1c SystemTaidoc Technology Corporation20160—
+2K130014A1C Gear SystemSakae Corporation20141—
+2K082275Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023Infopia Co, Ltd.20102—
+2K091711S- Test Hemoglobin Alc (HBA1C), Model RC0023Alfa Wassermann Diagnostic Technologies, Inc.20090—
+3K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation20260—
+3K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation20240—
+3K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS20230—
+3K142789A1c iGear SystemSakae Corporation20140—
+3K121366Hemocue HBA1C 501Infopia Co, Ltd.20121—
+4K141750Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring SystemInfopia Co, Ltd.20140—