510(k) Report

Devices descending from K853681

2 later devices reach Sigma 610 for Protein in Urine & CSF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc.199712
+2K060853Online TDM TobramycinRoche Diagnostics Corp.200602