FDA 510(k) Applications Submitted by Sophie Quiblier
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K250274 | 01/30/2025 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 ╡g/mL) | bioMerieux, SA |
| K232395 | 08/09/2023 | ETEST« Sulbactam/Durlobactam (SUD) (0.004/4-64/4 ╡g/mL), ETEST« SUD | bioMΘrieux |
| K192738 | 09/27/2019 | ETEST Delafloxacin (DFX) (0.002-32 ╡g/mL) | BioMerieux SA |
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