510(k) Report

Devices descending from K152075

1 later device reach VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161437VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)bioMerieux, Inc.20170—