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FDA 510(k)

Nano-Check™ COVID-19 Antigen Test

K-Number: K231187 · 2024-01-23

ApplicantNano-Ditech Corporation
Decision Date2024-01-23
Product CodeQVF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Nano-Check™ COVID-19 Antigen 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 2024-01-23 under 510(k) number K231187. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nano-Check™ COVID-19 Antigen Test?

Nano-Check™ COVID-19 Antigen Test is a medical device that received FDA 510(k) clearance on 2024-01-23. The listed applicant is Nano-Ditech Corporation. The 510(k) number is K231187.

When did Nano-Check™ COVID-19 Antigen Test receive FDA 510(k) clearance?

Nano-Check™ COVID-19 Antigen Test received FDA 510(k) clearance on 2024-01-23, under 510(k) number K231187.

Who is the listed applicant for Nano-Check™ COVID-19 Antigen 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™ COVID-19 Antigen Test?

The FDA product code for Nano-Check™ COVID-19 Antigen Test is QVF.

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 TestK243561Nano-Check Influenza+COVID-19 Dual TestK240280Nano-Check™ RSV Test

Related Devices (Code: QVF)

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.

K253882CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc.K251289WELLlife COVID-19 Antigen Test RxGuangzhou Wondfo Biotech Co., Ltd.K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and CompanyK250273BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc.K233358SCoV-2 Ag Detect Rapid TestInBios International, Inc.K232377Healgen Rapid COVID-19 Antigen TestHealgen Scientific,, LLC

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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