510(k) Report

Devices descending from K063597

20 later devices reach Vitek 2 Gram Positive Amoxicillin for Streptococcus Pneumoniae through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121100Vitek 2 Ast Streptococus VancomycinbioMerieux, Inc.201201
+1K122359Vitek 2 Strptococcus CeftriaxonebioMerieux, Inc.20121—
+1K121863Vitek 2 Ast-ST CefotaximebioMerieux, Inc.20122—
+1K113783Vitek 2 Ast- Gram Postive Penicillin for Streptococcus PneumoniaebioMerieux, Inc.20120—
+1K111893Vitek (R) 2 Streptococcus TetracyclinebioMerieux, Inc.20121—
+1K111976Vitek 2 Streptococcus ErythromycinbioMerieux, Inc.20120—
+1K113305Vitek 2 Streptococcus Trimethoprim/SulfamethoxazolebioMerieux, Inc.20120—
+1K112000Vitek 2 Streptococcus PenicillinbioMerieux, Inc.20113—
+1K112228Vitek 2 Streptococcus LevofloxacinbioMerieux, Inc.20110—
+1K112129Vitek (R) 2 Streptococcus ClindamycinbioMerieux, Inc.20110—
+1K112075Vitek 2 Strptococcus AmpicillinbioMerieux, Inc.20110—
+1K111599Vitek 2 Ast-ST LinezolidbioMerieux, Inc.20111—
+2K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus…bioMerieux, Inc.20232—
+2K223481VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)bioMerieux, Inc.20230—
+2K210287VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)bioMerieux, Inc.20210—
+2K132507Vitek 2 Ast ST MeropenembioMerieux, Inc.20130—
+2K131779Vitek 2 Ast-ST TigecyclinebioMerieux, Inc.20130—
+2K132573Vitek 2 Ast ST Moxifloxacin, Vitek 2 Ast Streptococcus MoxifloxacinbioMerieux, Inc.20130—
+3K260619VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)Biomérieux, Inc.20260—
+3K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)Biomerieux20260—