510(k) Report

Devices descending from K060325

2 later devices reach Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…Elitechgroup20170—
+1K110780Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…Elitechgroup20110—