510(k) K012595 ยท DJR Enzyme Immunoassay, Methadone
ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 15, 2001 |
| Received | Aug 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012595
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.