510(k) Report

Devices descending from K121610

2 later devices reach Cobas C 501 Tina-Quant HBA1CDX Gen.3 Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180296Afinion HbA1c DxAlere Technologies AS201811
+2K182988Afinion HbA1c Dx on Afinion 2Alere Technologies AS201801