FDA 510(k) Applications Submitted by BIOMERIEUX, INC

FDA 510(k) Number Submission Date Device Name Applicant
K152075 07/27/2015 VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) bioMerieux, Inc
K161227 05/02/2016 VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) BIOMERIEUX, INC
K161510 06/01/2016 VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) BIOMERIEUX, INC
K181766 07/03/2018 VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance bioMerieux, Inc
K172150 07/17/2017 Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) bioMerieux, Inc
K162737 09/30/2016 VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4?g/mL) bioMerieux, Inc
K163563 12/19/2016 VITEK 2 AST-GN Gentamicin (<=1 û >=16 ?g/mL) bioMerieux, Inc
K162827 10/07/2016 VIDAS B.R.A.H.M.S. PCT (PCT) bioMerieux, Inc
K160911 04/01/2016 VIDAS B.R.A.H.M.S. PCT (PCT) bioMerieux, Inc


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