510(k) K230238 · DJG Enzyme Immunoassay, Opiates
BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx
| Applicant | Shenzhen Bioeasy Biotechnology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 31, 2023 |
| Received | Jan 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230238
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.