510(k) Report

Devices descending from K072668

4 later devices reach Vitek 2 Gram Positive Vancomycin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091126Vitek 2 Gram Positive DaptomycinbioMerieux, Inc.20093—
+2K230864VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin…bioMerieux, Inc.20231—
+2K093076Vitek 2 Gram Positive DoxcyclinebioMerieux, Inc.20100—
+3K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)bioMerieux, Inc.20240—