510(k) K131168 ยท DJG Enzyme Immunoassay, Opiates
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
| Applicant | Immunalysis Corporation, Pomona CA, US |
| Decision | Substantially Equivalent, Jan 17, 2014 |
| Received | Apr 24, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131168
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.