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- MiscellaneousMiscellaneous
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- QYTOver-The-Counter Covid-19 Antigen Test2Product Code
- K243518BinaxNOW™ COVID-19 Antigen Self Test; BinaxNOW™ COVID-19 Ag Card2Cleared 510(K)
- K241915CareSuperb™ COVID-19 Antigen Home Test2Cleared 510(K)
- K241317Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)2Cleared 510(K)
- K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test2Cleared 510(K)
- K233842iHealth COVID-19 Antigen Rapid Test2Cleared 510(K)
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- SDNSerology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/PsUProduct Code
- SEATest For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K241317
- 510(k) Type
- Traditional
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/30/2024
- Days to Decision
- 143 days
- Submission Type
- Summary