510(k) Report

Devices descending from K072409

5 later devices reach Afinion Acr and Acr Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation20241—
+1K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics201722
+2K252206Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation20260—
+2K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation20240—
+2K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS20230—