Empowered Diagnostics LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0481-2022Class IImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60December 22, 2021
Z-0480-2022Class ICovClear COVID-19 Rapid Antigen Test, ATG 900-031December 22, 2021