510(k) Report

Devices descending from K981426

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992—
+2K131126Opti Cca-TS2Opti Medical Systems, Inc.20131—
+3K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.20210—