510(k) Report

Devices descending from K163563

1 later device reach VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223478VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin…bioMerieux, Inc.20230—