Wondfo USA Co Ltd

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2034-2024Class IIStreptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, GuApril 22, 2024
Z-2033-2024Class IIIndependent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid TesApril 22, 2024
Z-2031-2024Class IIClarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep April 22, 2024
Z-2030-2024Class IIPreview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10April 22, 2024
Z-2032-2024Class IIStreptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test aApril 22, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestAugust 20, 2025
K243256WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTestJanuary 16, 2025