Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
FDA 510(k) K241317 · Guangzhou Wondfo Biotech Co., Ltd.
510(k) numberK241317
Submission
- Device name
- Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
Guangzhou, CN - Received
- May 10, 2024
- Decision date
- September 30, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QYT – Over-The-Counter Covid-19 Antigen Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3984
- Specialty
- Microbiology
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
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|---|---|---|---|
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT · Traditional | Assure Tech., LLC | 06/05/2026SE |
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-TestQYT · Traditional | Healgen Scientific,, LLC | 04/13/2026SE |
| K251916 | GenBody COVID-19 Ag Home TestQYT · Traditional | Genbody.Inc. | 03/13/2026SE |
| K251595 | COVID-19 Detect Rapid Self -TestQYT · Traditional | InBios International, Inc. | 10/12/2025SE |
| K251753 | GenaCheck COVID-19 Rapid Self-TestQYT · Traditional | Genabio Diagnostics, Inc. | 09/05/2025SE |
| K241313 | OHC COVID-19 Antigen Self TestQYT · Traditional | Osang, LLC | 05/30/2025SE |
| K243518 | BinaxNOW COVID-19 Antigen Self TestQYT · Traditional | Abbott Diagnostics Scarborough, Inc. | 02/11/2025SE |
| K241915 | CareSuperb COVID-19 Antigen Home TestQYT · Traditional | Access Bio, Inc. | 01/29/2025SE |
| K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestQYT · Traditional | CorDx, Inc. | 06/21/2024SE |
| K233842 | iHealth COVID-19 Antigen Rapid TestQYT · Traditional | Ihealth Labs, Inc. | 05/31/2024SE |
More from Ihealth Labs, Inc.
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|---|---|---|
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxNFT · Traditional | 04/28/2026SE |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxNFT · Traditional | 11/18/2025SE |
| K251289 | WELLlife COVID-19 Antigen Test RxQVF · Dual Track | 10/22/2025SE |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test…NGL · Traditional | 07/16/2024SE |
| K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxNFT · Traditional | 09/25/2020SE |
| K182701 | Wondfo T-Cup Multi-Drug Urine Test CupNFT · Traditional | 12/03/2018SE |
| K173229 | Preview Digital Pregnancy TestLCX · Traditional | 03/12/2018SE |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional | 05/14/2017SE |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…DIO · Traditional | 06/27/2016SE |
| K152495 | Wondfo Propoxyphene Urine TestJXN · Traditional | 11/23/2015SE |
Questions and answers
When was Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) cleared by the FDA?
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (K241317) received a 510(k) decision of Substantially Equivalent on September 30, 2024, 143 days after the submission was received.
What is the product code of K241317?
The FDA product code is QYT – Over-The-Counter Covid-19 Antigen Test, a Class II (moderate risk) device regulated under 21 CFR 866.3984.