510(k) K113624 ยท DJG Enzyme Immunoassay, Opiates
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Mar 12, 2012 |
| Received | Dec 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113624
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.