510(k) K130055 ยท DJG Enzyme Immunoassay, Opiates
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Feb 14, 2013 |
| Received | Jan 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130055
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.