Documento fuente o registro público
FDA 510(k) K243561 — Nano-Check Influenza+COVID-19 Dual Test
FDA 510(k) index record K243561. Device: Nano-Check Influenza+COVID-19 Dual Test. Applicant as listed: Nano-Ditech Corporation. Decision date: 2025-06-17.
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"device_name": "Nano-Check Influenza+COVID-19 Dual Test"
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Automated FDA record verification
2026-10-20
2026-10-24
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FDA 510(k) public index record K243561.
Device name: Nano-Check Influenza+COVID-19 Dual Test. Applicant as listed: Nano-Ditech Corporation.
Decision date: 2025-06-17. Decision wording: Substantially Equivalent.
Product code: SCA. Regulation: 21 CFR 866.3987. 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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