510(k) K112071 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Sep 23, 2011 |
| Received | Jul 20, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112071
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.