510(k) K011353 ยท DJG Enzyme Immunoassay, Opiates
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 30, 2001 |
| Received | May 3, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011353
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.