510(k) Report

Devices descending from K012058

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp.20111—
+2K112955Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation20120—