Documento fuente o registro público

FDA 510(k) K230479 — ComASP Cefiderocol 0.008-128

FDA 510(k) index record K230479. Device: ComASP Cefiderocol 0.008-128. Applicant as listed: Liofilchem s.r.l.. Decision date: 2023-05-18.

OtherU.S. Food and Drug Administration (FDA)2023-05-18

Fuente

"device_name": "ComASP Cefiderocol 0.008-128"

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-29

Disclaimer

professional use

FDA 510(k) public index record K230479.

Device name: ComASP Cefiderocol 0.008-128. Applicant as listed: Liofilchem s.r.l..

Decision date: 2023-05-18. Decision wording: Substantially Equivalent.

Product code: JWY. Regulation: 21 CFR 866.1640. Medical specialty: Microbiology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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