510(k) Report

Devices descending from K092454

9 later devices reach Vitek 2 Yeast Voriconazole through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133952Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast FlucytosinebioMerieux, Inc.20145—
+1K133817Vitek 2 Ast - Yeast FluconazolebioMerieux, Inc.20142—
+2K213241VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64…bioMerieux, Inc.20221—
+2K151923VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)bioMerieux, Inc.20161—
+2K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc.20162—
+3K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc.20240—
+3K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125…bioMerieux, Inc.20221—
+3K181368VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)bioMerieux, Inc.20180—
+4K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc.20240—