510(k) Report

Devices descending from K050075

6 later devices reach Vitek 2 Gram Positive Daptomycin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072695Vitek 2 Gram Positive TigecyclinebioMerieux, Inc.20070—
+1K072668Vitek 2 Gram Positive VancomycinbioMerieux, Inc.20074—
+2K091126Vitek 2 Gram Positive DaptomycinbioMerieux, Inc.20093—
+3K230864VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin…bioMerieux, Inc.20231—
+3K093076Vitek 2 Gram Positive DoxcyclinebioMerieux, Inc.20100—
+4K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)bioMerieux, Inc.20240—