Documento fuente o registro público

FDA 510(k) K201849 — eNAT molecular collection and preservation medium

FDA 510(k) index record K201849. Device: eNAT molecular collection and preservation medium. Applicant as listed: Copan Italia Spa. Decision date: 2020-09-17.

OtherU.S. Food and Drug Administration (FDA)2020-09-17

Fuente

"device_name": "eNAT molecular collection and preservation medium"

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

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K201849.

Device name: eNAT molecular collection and preservation medium. Applicant as listed: Copan Italia Spa.

Decision date: 2020-09-17. Decision wording: Substantially Equivalent.

Product code: QBD. Regulation: 21 CFR 866.2950. 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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