510(k) K043507 ยท DJG Enzyme Immunoassay, Opiates
ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 25, 2005 |
| Received | Dec 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043507
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.