Documento fuente o registro público

FDA 510(k) K213611 — Fenom Pro

FDA 510(k) index record K213611. Device: Fenom Pro. Applicant as listed: Caire Diagnostics, Inc.. Decision date: 2023-06-07.

OtherU.S. Food and Drug Administration (FDA)2023-06-07

Fuente

"device_name": "Fenom Pro"
api.fda.gov · Consultado el 2026-10-28

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

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Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-29

Disclaimer

professional use

References

FDA 510(k) public index record K213611.

Device name: Fenom Pro. Applicant as listed: Caire Diagnostics, Inc..

Decision date: 2023-06-07. Decision wording: Substantially Equivalent.

Product code: MXA. Regulation: 21 CFR 862.3080. Medical specialty: Clinical Toxicology.

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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FDA 510(k) K213611 — Fenom Pro

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