510(k) Report

Devices descending from K180428

2 later devices reach Stat Profile Prime Plus Analyzer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation202012
+2K252475ABL90 FLEX PLUS SystemRadiometer Medicals Aps20260—