510(k) Report

Devices descending from K040280

5 later devices reach Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132156Randox CSF Controls Levels 2 and 3Randox Laboratories, Ltd.20130—
+1K062379Cobas Integra CeruloplasminRoche Diagnostics Corp.20070—
+1K041812Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath…Roche Diagnostics Corp.20042—
+2K050026Precinorm Proteins in Urine/CSF (Puc) and Precipath PucRoche Diagnostics20051—
+3K071779Abx Pentra Urine CalHoriba Abx20080—