Documento fuente o registro público

FDA 510(k) K252283 — Nano-Check Influenza A+B Test

FDA 510(k) index record K252283. Device: Nano-Check Influenza A+B Test. Applicant as listed: Nano-Ditech Corporation. Decision date: 2026-01-15.

OtherU.S. Food and Drug Administration (FDA)2026-01-15

Fuente

"device_name": "Nano-Check Influenza A+B Test"

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

FDA 510(k) public index record K252283.

Device name: Nano-Check Influenza A+B Test. Applicant as listed: Nano-Ditech Corporation.

Decision date: 2026-01-15. Decision wording: Substantially Equivalent.

Product code: PSZ. Regulation: 21 CFR 866.3328. 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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