510(k) K161214 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Jun 27, 2016 |
| Received | Apr 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161214
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.