Ihealth Labs, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProDecember 12, 2025
K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProDecember 12, 2025
K243146iCare APPFebruary 3, 2025
K233842iHealth COVID-19 Antigen Rapid TestMay 31, 2024