510(k) Report

Devices descending from K780563

2 later devices reach Single Vial Lactate through their predicates, nearest generation first.

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