510(k) Report

Devices descending from K053097

5 later devices reach Vitek 2 Gram Positive Cefoxitin Screen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220805VITEK 2 AST-Gram Positive Cefoxitin ScreenbioMerieux, Inc.20220—
+1K080201Vitek 2 Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc.20083—
+2K111909Vitek 2 Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.20112—
+3K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.20260—
+3K181766VITEK 2 AST-Gram Positive Inducible Clindamycin ResistancebioMerieux, Inc.20180—