510(k) Report

Devices descending from K063498

3 later devices reach Hydragel 18 A1AT Isofocusing Kit (PN 4356) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171868A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company20172—
+2K192858A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company20191—
+3K211115A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company20210—