510(k) K243064 ยท NGL Test, Opiates, Over The Counter
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
| Applicant | Eterbio, Inc., Zhuhai, CN |
| Decision | Substantially Equivalent, Nov 20, 2024 |
| Received | Sep 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243064
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.