510(k) K003209 ยท DJG Enzyme Immunoassay, Opiates
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Dec 5, 2000 |
| Received | Oct 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003209
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.