510(k) K110298 ยท DJG Enzyme Immunoassay, Opiates
OPIATE ENZYME IMMUNOASSAY
| Applicant | Lin-Zhi International, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 15, 2011 |
| Received | Feb 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110298
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.