510(k) K000458 ยท JXM Enzyme Immunoassay, Benzodiazepine
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 17, 2000 |
| Received | Feb 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000458
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.