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510(k) K241317

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) by Guangzhou Wondfo Biotech Co., Ltd. — Product Code QYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2024
Date Received
May 10, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Covid-19 Antigen Test
Device Class
Class II
Regulation Number
866.3984
Review Panel
MI
Submission Type

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

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  • K202567 — Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Pan (September 25, 2020)
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  • K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test (May 14, 2017)
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Other clearances for product code QYT

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  • K241313 — OHC COVID-19 Antigen Self Test (May 30, 2025)
  • K243518 — BinaxNOW™ COVID-19 Antigen Self Test (February 11, 2025)
  • K241915 — CareSuperb™ COVID-19 Antigen Home Test (January 29, 2025)
  • K240728 — CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test (June 21, 2024)
  • K233842 — iHealth COVID-19 Antigen Rapid Test (May 31, 2024)
  • K233373 — Flowflex® Plus COVID-19 Home Test (April 19, 2024)
  • K231795 — QuickVue COVID-19 Test (March 22, 2024)