Wondfo USA Co Ltd

Medical device manufacturer in San Diego, CA.

2510(k) clearances
0PMA approvals
5recalls

Device types

510(k) clearances

510(k)DeviceDecision
K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestSCA · Traditional 08/20/2025SE
K243256WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B…SCA · Traditional 01/16/2025SE

Recalls

RecallProductInitiated
Z-2034-2024 Class IIStreptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A…Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized… 04/22/2024Open, Classified
Z-2033-2024 Class IIIndependent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep…Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized… 04/22/2024Open, Classified
Z-2032-2024 Class IIStreptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A…Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized… 04/22/2024Open, Classified
Z-2031-2024 Class IIClarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a)…Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized… 04/22/2024Open, Classified
Z-2030-2024 Class IIPreview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b)…Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized… 04/22/2024Open, Classified