510(k) K251085 ยท SCA Multi-Analyte Respiratory Virus Antigen Detection Test
iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
| Applicant | Ihealth Labs, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 12, 2025 |
| Received | Apr 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251085
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.