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CUE HEALTH INC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0091-2025Class IICue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home andMay 24, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K232643Cue COVID-19 Molecular TestNovember 28, 2023
DEN220028Cue COVID-19 Molecular TestJune 6, 2023