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Ihealth Labs, Inc. FDA Approvals
0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro510(k)Dec 12, 2025Microbiology |
| iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro510(k)Dec 12, 2025Microbiology |
| iCare APP510(k)Feb 3, 2025Cardiovascular |
| iHealth COVID-19 Antigen Rapid Test510(k)May 31, 2024Microbiology |