510(k) Report

Devices descending from K935376

3 later devices reach Axsym Gentamicin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102699Architect Igentamicin Reagents; Architect Igentamicin CalibratorsAbbott Laboratories201111
+1K012311Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests)Diagnostic Products Corp.20010—
+2K243500ARCHITECT iGentamicinAbbott Laboratories20250—