510(k) Report

Devices descending from K922043

1 later device reach Roche Calibrator Serum through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982848Cobas Integra LDL Direct Reagent Cassette Roche Calibrator LDL DirectRoche Diagnostic Systems, Inc.19980—