510(k) K053337 ยท DKZ Enzyme Immunoassay, Amphetamine
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, May 19, 2006 |
| Received | Dec 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053337
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.