Documento fuente o registro público

FDA 510(k) K231536 — eQUANT System

FDA 510(k) index record K231536. Device: eQUANT System. Applicant as listed: Avails Medical, Inc.. Decision date: 2024-02-08.

OtherU.S. Food and Drug Administration (FDA)2024-02-08

Fuente

"device_name": "eQUANT 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

2026-10-27

Disclaimer

professional use

FDA 510(k) public index record K231536.

Device name: eQUANT System. Applicant as listed: Avails Medical, Inc..

Decision date: 2024-02-08. Decision wording: Substantially Equivalent.

Product code: QZX. Regulation: 21 CFR 866.1650. 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