510(k) K143535 ยท DIS Enzyme Immunoassay, Barbiturate
CR3 Keyless Split Sample Cup Secobarbital- Methadone
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Jan 13, 2015 |
| Received | Dec 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143535
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.