510(k) Report

Devices descending from K151817

2 later devices reach VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125…bioMerieux, Inc.20221—
+2K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc.20240—