510(k) Report

Devices descending from K232201

2 later devices reach VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260619VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)Biomérieux, Inc.20260—
+1K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)Biomerieux20260—