510(k) K220046 ยท DJG Enzyme Immunoassay, Opiates
Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
| Applicant | Shenzhen Superbio Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 13, 2022 |
| Received | Jan 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220046
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.