510(k) Report

Devices descending from K992511

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030799Micros 60Abx Diagnostics20031—
+1K030144Modification to Pentra 60 and Pentra 60C+Abx Diagnostics20030—
+2K141161Abx Micros ES 60 CT; (Open Tube Model), (Close Tube Model)Horiba Abx Sas20140—