510(k) K221605 · DJG Enzyme Immunoassay, Opiates
Emit® II Plus Buprenorphine Assay
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 25, 2023 |
| Received | Jun 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221605
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.