Documento fuente o registro público

FDA 510(k) K252481 — cobas CMV

FDA 510(k) index record K252481. Device: cobas CMV. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2025-11-03.

OtherU.S. Food and Drug Administration (FDA)2025-11-03

Fuente

"device_name": "cobas CMV"
api.fda.gov · Consultado el 2026-10-23

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

2026-10-24

Disclaimer

professional use

References

FDA 510(k) public index record K252481.

Device name: cobas CMV. Applicant as listed: Roche Molecular Systems, Inc..

Decision date: 2025-11-03. Decision wording: Substantially Equivalent.

Product code: PAB. Regulation: 21 CFR 866.3180. 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) K252481 — cobas CMV

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