510(k) Report

Devices descending from K161227

5 later devices reach VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc.20173—
+1K163006VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)bioMerieux, Inc.20170—
+2K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc.201921
+3K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)bioMerieux, Inc.20201—
+4K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)bioMerieux, Inc.202101