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FDA 510(k) Applications Submitted by Debra Broyles
FDA 510(k) Number
Submission Date
Device Name
Applicant
K220805
03/18/2022
VITEK 2 AST-Gram Positive Cefoxitin Screen
bioMerieux, Inc
K201675
06/19/2020
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 ╡g/mL)
bioMerieux, Inc.
K202396
08/21/2020
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
bioMerieux, Inc.
K213931
12/16/2021
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 ╡g/mL)
bioMerieux, Inc.
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