CUE HEALTH INC

FDA Regulatory Profile

CUE HEALTH INC appears in FDA public data with 1 recall, 2 510(k) clearances, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (Z-0091-2025, Class II) was initiated on May 24, 2024. Its most recent 510(k) clearance was granted on November 28, 2023.

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