FDA 510(k)

Nano-Check Influenza+COVID-19 Dual Test

K-Number: K243561 · 2025-06-17

Decision Date2025-06-17

Product CodeSCA

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Nano-Check Influenza+COVID-19 Dual Test is a medical device manufactured by Nano-Ditech Corporation. It received FDA 510(k) clearance on 2025-06-17 under approval number K243561. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nano-Check Influenza+COVID-19 Dual Test?

Nano-Check Influenza+COVID-19 Dual Test is a medical device that received FDA 510(k) clearance on 2025-06-17. It is manufactured by Nano-Ditech Corporation. The 510(k) number is K243561.

When was Nano-Check Influenza+COVID-19 Dual Test approved by the FDA?

Nano-Check Influenza+COVID-19 Dual Test received FDA 510(k) clearance on 2025-06-17, under approval number K243561.

What company makes Nano-Check Influenza+COVID-19 Dual Test?

Nano-Check Influenza+COVID-19 Dual Test is manufactured by Nano-Ditech Corporation.

What is the FDA product code for Nano-Check Influenza+COVID-19 Dual Test?

The FDA product code for Nano-Check Influenza+COVID-19 Dual Test is SCA.

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Other Devices by Nano-Ditech Corporation

K240280Nano-Check RSV Test K231187Nano-Check COVID-19 Antigen Test K252283Nano-Check Influenza A+B Test

Related Devices (Code: SCA)

DEN240029Healgen Rapid Check COVID-19/Flu A&B Antigen TestHealgen K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProIhealth Labs, Inc. K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc. K251538Status COVID-19/Flu A&BPrinceton BioMeditech Corp. K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc. K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.