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FDA 510(k)

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

K-Number: K241317 · 2024-09-30

ApplicantGuangzhou Wondfo Biotech Co., Ltd.
Decision Date2024-09-30
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a medical device manufactured by Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-09-30 under approval number K241317. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)?

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a medical device that received FDA 510(k) clearance on 2024-09-30. It is manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K241317.

When was Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) approved by the FDA?

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) received FDA 510(k) clearance on 2024-09-30, under approval number K241317.

What company makes Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)?

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is manufactured by Guangzhou Wondfo Biotech Co., Ltd..

What is the FDA product code for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)?

The FDA product code for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is QYT.

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Related Devices (Code: QYT)

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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.

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