510(k) K093175 ยท DJG Enzyme Immunoassay, Opiates
WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Greenville DE, US |
| Decision | Substantially Equivalent, Aug 25, 2010 |
| Received | Oct 8, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093175
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.