510(k) Report

Devices descending from K190616

3 later devices reach VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) through their predicates, nearest generation first.

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