510(k) K080057 ยท DKZ Enzyme Immunoassay, Amphetamine
IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLATE, IMDXPREP CONTROL
| Applicant | Novx Systems, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Oct 31, 2008 |
| Received | Jan 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080057
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.