510(k) Report

Devices descending from K072038

26 later devices reach Vitek 2 Gram Negative Levofloxacin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222378VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)bioMerieux, Inc.20230—
+1K082346Vitek 2 Gram Negative DoripenembioMerieux, Inc.200922—
+1K080107Vitek 2 Gram Negative Piperacillin/TazobactambioMerieux, Inc.20080114
+1K073083Vitek 2 Gram Negative PiperacillinbioMerieux, Inc.20070—
+2K091899Vitek 2 Gram Negative MeropenembioMerieux, Inc.200921—
+3K110106Vitek 2 Gram Negative Trimethoprim/SulfamethoazolebioMerieux, Inc.20110—
+3K103752Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc.201119—
+4K220546Colibrí SystemCopan Wasp Srl20222—
+4K121546Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc.201215—
+5K223245ColibríCopan Wasp Srl20231—
+5K162737VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)bioMerieux, Inc.20170—
+5K163637BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)Becton Dickinson & Company20170—
+5K163563VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)bioMerieux, Inc.20171—
+5K161510VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)bioMerieux, Inc.20171—
+5K161217VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)bioMerieux, Inc.20170Class I
+5K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc.20165—
+5K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)bioMerieux, Inc.201611
+6K232756ColibríCopan Wasp Srl20230—
+6K223478VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin…bioMerieux, Inc.20230—
+6K172944VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mLbioMerieux, Inc.201701
+6K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc.20173—
+6K161437VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)bioMerieux, Inc.20170—
+6K163006VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)bioMerieux, Inc.20170—
+7K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)bioMerieux, Inc.201921
+8K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)bioMerieux, Inc.20201—
+9K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)bioMerieux, Inc.202101