510(k) Report

Devices descending from DEN170081

5 later devices reach MALDI Biotyper CA System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193138Colibri SystemCopan Wasp Srl20210—
+1K191964BD Kiestra IdentifABecton, Dickinson and Company20211—
+1K181412Vitek MSbioMerieux, Inc.20182—
+2K222563BD Kiestra IdentifABecton, Dickinson and Company20230—
+2K212461Vitek MS PrimebioMerieux, Inc.20220—