510(k) Report

Devices descending from K032766

14 later devices reach Vitek 2 Gram Positive Linezolid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212849VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)Biomérieux, Inc.20220—
+1K122547Gram Postitve ClindamycinbioMerieux, Inc.20125—
+1K050075Vitek 2 Gram Positive DaptomycinbioMerieux, Inc.20056—
+2K141149Vitek 2 Ast GP CeftarolinebioMerieux, Inc.20144—
+2K072695Vitek 2 Gram Positive TigecyclinebioMerieux, Inc.20070—
+2K072668Vitek 2 Gram Positive VancomycinbioMerieux, Inc.20074—
+3K190616VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)bioMerieux, Inc.20193—
+3K091126Vitek 2 Gram Positive DaptomycinbioMerieux, Inc.20093—
+4K230864VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin…bioMerieux, Inc.20231—
+4K212243VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)bioMerieux, Inc.20220—
+4K202396VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)bioMerieux, Inc.20210—
+4K200590VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)bioMerieux, Inc.20200—
+4K093076Vitek 2 Gram Positive DoxcyclinebioMerieux, Inc.20100—
+5K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)bioMerieux, Inc.20240—