510(k) K040274 ยท DJG Enzyme Immunoassay, Opiates
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 3, 2004 |
| Received | Feb 5, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040274
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.