510(k) Report

Devices descending from K960120

9 later devices reach Stat Profile Ultra F,G,H,I,J, and K Analyzers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990092Avl Omni Modular AnalyzerAvl Scientific Corp.199974
+1K972733Avl Omni AnalyzerAvl Scientific Corp.199706
+2K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.200504
+2K032311Roche Diagnostics Omni S AnalyzerRoche Diagnostics Corp.200319
+2K013373Omni C AnalyzerRoche Diagnostics Corp.200121
+2K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992—
+3K131126Opti Cca-TS2Opti Medical Systems, Inc.20131—
+3K111188Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack…Roche Diagnostics201204
+4K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—