510(k) Report

Devices descending from K981401

7 later devices reach Boehringer Mannheim Precinorm Precipath Protein Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133330C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein &…Roche Diagnostics20130—
+1K040280Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR ControlsRoche Diagnostics Corp.20045—
+2K132156Randox CSF Controls Levels 2 and 3Randox Laboratories, Ltd.20130—
+2K062379Cobas Integra CeruloplasminRoche Diagnostics Corp.20070—
+2K041812Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath…Roche Diagnostics Corp.20042—
+3K050026Precinorm Proteins in Urine/CSF (Puc) and Precipath PucRoche Diagnostics20051—
+4K071779Abx Pentra Urine CalHoriba Abx20080—