510(k) Report

Devices descending from K013373

2 later devices reach Omni C Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032311Roche Diagnostics Omni S AnalyzerRoche Diagnostics Corp.200319
+2K111188Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack…Roche Diagnostics201204