FDA 510(k)

Nano-Check™ RSV Test

K-Number: K240280 · 2024-07-30

Decision Date2024-07-30

Product CodeGQG

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Nano-Check™ RSV 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 2024-07-30 under 510(k) number K240280. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nano-Check™ RSV Test?

Nano-Check™ RSV Test is a medical device that received FDA 510(k) clearance on 2024-07-30. The listed applicant is Nano-Ditech Corporation. The 510(k) number is K240280.

When did Nano-Check™ RSV Test receive FDA 510(k) clearance?

Nano-Check™ RSV Test received FDA 510(k) clearance on 2024-07-30, under 510(k) number K240280.

Who is the listed applicant for Nano-Check™ RSV 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™ RSV Test?

The FDA product code for Nano-Check™ RSV Test is GQG.

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 Test K243561Nano-Check Influenza+COVID-19 Dual Test K231187Nano-Check™ COVID-19 Antigen Test

Related Devices (Code: GQG)

K253318Clungene RSV Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd.K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation

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.