FDA 510(k) Applications Submitted by Mary Beth Anheuser

FDA 510(k) Number Submission Date Device Name Applicant
K183166 11/15/2018 BacT/ALERT FA Plus; BacT/ALERT PF Plus bioMerieux, Inc.
K211630 05/27/2021 VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 ╡g/mL) bioMerieux, Inc
K163083 11/03/2016 VITEK 2 AST-GN Tobramycin (/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (/=16 ug/mL) bioMerieux, Inc.


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