510(k) K153741 ยท LDJ Enzyme Immunoassay, Cannabinoids
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
| Applicant | Hangzhou Clongene Biotech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Mar 18, 2016 |
| Received | Dec 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153741
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.