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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 (=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (=1->/=16 ug/mL)
bioMerieux, Inc.
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