510(k) K190412 ยท NGL Test, Opiates, Over The Counter
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
| Applicant | Hangzhou Clongene Biotech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Mar 21, 2019 |
| Received | Feb 21, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190412
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.