FDA 510(k)

Nano-Check COVID-19 Antigen Test

K-Number: K231187 · 2024-01-23

Decision Date2024-01-23

Product CodeQVF

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Nano-Check COVID-19 Antigen Test is a medical device manufactured by Nano-Ditech Corporation. It received FDA 510(k) clearance on 2024-01-23 under approval 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. It is manufactured by Nano-Ditech Corporation. The 510(k) number is K231187.

When was Nano-Check COVID-19 Antigen Test approved by the FDA?

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

What company makes Nano-Check COVID-19 Antigen Test?

Nano-Check COVID-19 Antigen Test is manufactured by Nano-Ditech Corporation.

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.

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Related Devices (Code: QVF)

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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.