Documento fuente o registro público

FDA 510(k) K254167 — MDx-Chex for BCY

FDA 510(k) index record K254167. Device: MDx-Chex for BCY. Applicant as listed: Streck, LLC. Decision date: 2026-03-17.

OtherU.S. Food and Drug Administration (FDA)2026-03-17

Fuente

"device_name": "MDx-Chex for BCY"
api.fda.gov · Consultado el 2026-10-22

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

2026-10-23

Disclaimer

professional use

References

FDA 510(k) public index record K254167.

Device name: MDx-Chex for BCY. Applicant as listed: Streck, LLC.

Decision date: 2026-03-17. Decision wording: Substantially Equivalent.

Product code: PMN. Regulation: 21 CFR 866.3920. 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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FDA 510(k) K254167 — MDx-Chex for BCY

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