Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
Summary
Guangzhou Wondfo Biotech Co., Ltd. received 510(k) clearance for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method), a QYT device. Cleared on 2024-09-30.
Details
Source
510(k) Clearance
External ID
K241317
Action Date
2024-09-30
Status
Traditional
Category
device
Product Code
QYT
Product Description
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method). Product code: QYT.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 389 device clearances issued this month. Guangzhou Wondfo Biotech Co., Ltd. has received 5 total clearances in our database.
Guangzhou Wondfo Biotech Co., Ltd. has 5 FDA actions in our database, including 5 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Guangzhou Wondfo Biotech Co., Ltd. have FDA actions?
Guangzhou Wondfo Biotech Co., Ltd. has 5 FDA actions in our database, including 0 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K241317" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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