Company · US
Wondfo USA Co Ltd
FDA 510(k) clearances and medical device recalls filed under this name, 2025 to 2025. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2024 | Wondfo USA Co Ltd Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, St Open, Classified |
GTY | None listed |
| Jun 7, 2024 | Wondfo USA Co Ltd Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC Open, Classified |
GTY | None listed |
| Jun 7, 2024 | Wondfo USA Co Ltd Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100 Open, Classified |
GTY | None listed |
| Jun 7, 2024 | Wondfo USA Co Ltd Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Num Open, Classified |
GTY | None listed |
| Jun 7, 2024 | Wondfo USA Co Ltd Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10 Open, Classified |
GTY | None listed |