Documento fuente o registro público

FDA 510(k) K220546 — Colibrí System

FDA 510(k) index record K220546. Device: Colibrí System. Applicant as listed: Copan Wasp Srl. Decision date: 2022-10-05.

OtherU.S. Food and Drug Administration (FDA)2022-10-05

Fuente

"device_name": "Colibrí System"

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

2026-10-30

Disclaimer

professional use

FDA 510(k) public index record K220546.

Device name: Colibrí System. Applicant as listed: Copan Wasp Srl.

Decision date: 2022-10-05. Decision wording: Substantially Equivalent.

Product code: LON. Regulation: 21 CFR 866.1645. 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.

Interested in these solutions?

Submit a sourcing request with the assays, volumes, and timeline of your own project.

Explorar más