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.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact