Documento fuente o registro público

FDA 510(k) K231465 — Q-Pad Test System

FDA 510(k) index record K231465. Device: Q-Pad Test System. Applicant as listed: Qurasense. Decision date: 2023-12-06.

OtherU.S. Food and Drug Administration (FDA)2023-12-06

Fuente

"device_name": "Q-Pad Test System"
api.fda.gov · Consultado el 2026-10-27

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

2026-10-28

Disclaimer

professional use

References

FDA 510(k) public index record K231465.

Device name: Q-Pad Test System. Applicant as listed: Qurasense.

Decision date: 2023-12-06. Decision wording: Substantially Equivalent.

Product code: LCP. Regulation: 21 CFR 864.7470. Medical specialty: Hematology.

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) K231465 — Q-Pad Test System

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