510(k) K241100 ยท NGL Test, Opiates, Over The Counter
Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
| Applicant | Co-Innovation Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, May 22, 2024 |
| Received | Apr 22, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241100
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.