510(k) K233842 ยท QYT Over-The-Counter Covid-19 Antigen Test
iHealth COVID-19 Antigen Rapid Test
| Applicant | Ihealth Labs, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 31, 2024 |
| Received | Dec 4, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233842
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.