510(k) Report

Devices descending from K041812

2 later devices reach Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050026Precinorm Proteins in Urine/CSF (Puc) and Precipath PucRoche Diagnostics20051—
+2K071779Abx Pentra Urine CalHoriba Abx20080—