510(k) Report

Devices descending from K091899

21 later devices reach Vitek 2 Gram Negative Meropenem through their predicates, nearest generation first.

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