510(k) K112310 ยท DJG Enzyme Immunoassay, Opiates
WONDFO METHADONE URINE TEST,OPIATE TEST
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Sep 8, 2011 |
| Received | Aug 10, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112310
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.