510(k) K232597 · DJG Enzyme Immunoassay, Opiates
LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
| Applicant | Hangzhou Laihe Biotech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Jan 9, 2024 |
| Received | Aug 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232597
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.