Cleared Traditional

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

K241317 · Guangzhou Wondfo Biotech Co., Ltd. · Microbiology

Sep 2024

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K241317 is an FDA 510(k) clearance for the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method), a Over-the-counter Covid-19 Antigen Test (Class II — Special Controls, product code QYT), submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on September 30, 2024, 143 days after receiving the submission on May 10, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3984.

Submission Details

510(k) Number	K241317 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2024
Decision Date	September 30, 2024
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QYT — Over-the-counter Covid-19 Antigen Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3984
Definition	For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older.