510(k) K060466 ยท DJG Enzyme Immunoassay, Opiates
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 21, 2006 |
| Received | Feb 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060466
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.