510(k) Report

Devices descending from K183415

2 later devices reach VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)bioMerieux, Inc.20201—
+2K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)bioMerieux, Inc.202101