510(k) Report

Devices descending from K171868

2 later devices reach A1AT Genotyping Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192858A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company20191—
+2K211115A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company20210—