510(k) DEN240029 ยท SCA Multi-Analyte Respiratory Virus Antigen Detection Test
Healgen Rapid Check COVID-19/Flu A&B Antigen Test
| Applicant | Healgen, Houston TX, US |
| Decision | Unknown, Oct 7, 2024 |
| Received | Jun 7, 2024 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN240029
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.