Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)— 510(k) K241317
Substantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearance K241317 for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method), Substantially Equivalent on 2024-09-30. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Product code
- Code QYT
- Device class
- Class 2
- Regulation
- 21 CFR 866.3984
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.