510(k) Report

Devices descending from K133952

5 later devices reach Vitek 2 Ast YS Flucytosine, Vitek 2 Ast Yeast Flucytosine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151923VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)bioMerieux, Inc.20161—
+1K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc.20162—
+2K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125…bioMerieux, Inc.20221—
+2K181368VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)bioMerieux, Inc.20180—
+3K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc.20240—