510(k) K040445 ยท JXN Enzyme Immunoassay, Propoxyphene
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 19, 2004 |
| Received | Feb 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040445
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.