510(k) Report

Devices descending from K940918

11 later devices reach I-Stat 200 Portable Clinical Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013624Modification to Agilent Component Monitoring System (CMS), V24/V26 Patient Monitors…Philips Medizin Systeme Boblingen GmbH20010—
+1K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992—
+1K990092Avl Omni Modular AnalyzerAvl Scientific Corp.199974
+1K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp.19984—
+1K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp.19985—
+2K131126Opti Cca-TS2Opti Medical Systems, Inc.20131—
+2K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.200504
+2K032311Roche Diagnostics Omni S AnalyzerRoche Diagnostics Corp.200319
+2K013373Omni C AnalyzerRoche Diagnostics Corp.200121
+3K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—
+3K111188Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack…Roche Diagnostics201204