510(k) K010561 ยท DIS Enzyme Immunoassay, Barbiturate
VERDICT -II BAR/BZO
| Applicant | Medtox Diagnostics, Inc., Burlington NC, US |
| Decision | Substantially Equivalent, Apr 5, 2001 |
| Received | Feb 26, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010561
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.