510(k) Report

Devices descending from K151809

6 later devices reach Alere Afinion HbA1c, Alere Afinion AS100 Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies AS20230—
+1K192987Aina HbA1c Monitoring System 2Jana Care, Inc.20200—
+1K180509Quo-Test A1c SystemEkf-Diagnostic GmbH20190—
+1K173127skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…Skyla Corporation H.S.P.B20180—
+1K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics201722
+2K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical Corporation20240—