510(k) K161251 ยท DKZ Enzyme Immunoassay, Amphetamine
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
| Applicant | Hangzhou Clongene Biotech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Aug 30, 2016 |
| Received | May 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161251
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.