510(k) Report

Devices descending from K141149

4 later devices reach Vitek 2 Ast GP Ceftaroline through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190616VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)bioMerieux, Inc.20193—
+2K212243VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)bioMerieux, Inc.20220—
+2K202396VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)bioMerieux, Inc.20210—
+2K200590VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)bioMerieux, Inc.20200—