Medical Device Manufacturer · US , Sunnyvale , CA

Ihealth Labs, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2024
4
Total
4
Cleared
0
Denied

FDA 510(k) cleared devices by Ihealth Labs, Inc. Microbiology ✕

3 devices
1-3 of 3
Cleared Dec 12, 2025
iHealth Flu A&B/COVID-19/RSV Rapid Test
K251085 · SCA
Microbiology · 247d
Cleared Dec 12, 2025
iHealth Flu A&B/COVID-19 Rapid Test
K251092 · SCA
Microbiology · 246d
Cleared May 31, 2024
iHealth COVID-19 Antigen Rapid Test
K233842 · QYT
Microbiology · 179d
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