510(k) Report

Devices descending from K003677

3 later devices reach Abx Pentra 60C+ Hematology Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030144Modification to Pentra 60 and Pentra 60C+Abx Diagnostics20030—
+1K024002Pentra 80Abx Diagnostics200312
+2K151133Pentra XLRHoriba Abx Sas20150—