510(k) Report

Devices descending from K955908

2 later devices reach Boehringer Mannheim Igm Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040431Roche Diagnostics Tina-Quant Igm Gen.2Roche Diagnostics Corp.200401
+1K982382Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc.199801