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FDA 510(k)

Nano-Check Influenza+COVID-19 Dual Test

K-Number: K243561 · 2025-06-17

ApplicantNano-Ditech Corporation
Decision Date2025-06-17
Product CodeSCA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Nano-Check Influenza+COVID-19 Dual Test is the device name listed in this FDA 510(k) record. The listed applicant is Nano-Ditech Corporation. It received FDA 510(k) clearance on 2025-06-17 under 510(k) 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. The listed applicant is Nano-Ditech Corporation. The 510(k) number is K243561.

When did Nano-Check Influenza+COVID-19 Dual Test receive FDA 510(k) clearance?

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

Who is the listed applicant for Nano-Check Influenza+COVID-19 Dual Test?

The FDA 510(k) record lists Nano-Ditech Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Nano-Ditech Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252283Nano-Check Influenza A+B TestK240280Nano-Check™ RSV TestK231187Nano-Check™ COVID-19 Antigen Test

Related Devices (Code: SCA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc.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.

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