Documento fuente o registro público

FDA 510(k) K220176 — Elecsys AFP

FDA 510(k) index record K220176. Device: Elecsys AFP. Applicant as listed: Roche Diagnostics. Decision date: 2022-09-15.

OtherU.S. Food and Drug Administration (FDA)2022-09-15

Fuente

"device_name": "Elecsys AFP"
api.fda.gov · Consultado el 2026-10-29

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

2026-10-30

Disclaimer

professional use

References

FDA 510(k) public index record K220176.

Device name: Elecsys AFP. Applicant as listed: Roche Diagnostics.

Decision date: 2022-09-15. Decision wording: Substantially Equivalent.

Product code: LOJ. Regulation: 21 CFR 866.6010. Medical specialty: Immunology.

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) K220176 — Elecsys AFP

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