510(k) K012824 ยท DIS Enzyme Immunoassay, Barbiturate
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 9, 2001 |
| Received | Aug 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012824
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.