510(k) K000459 ยท DIS Enzyme Immunoassay, Barbiturate
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 3, 2000 |
| Received | Feb 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000459
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.