510(k) Report

Devices descending from K171650

2 later devices reach Alere Afinion HbA1c and ACR on Afinion 2 analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation20240—
+1K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS20230—