510(k) K110446 ยท DKZ Enzyme Immunoassay, Amphetamine
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 3, 2011 |
| Received | Feb 16, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110446
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.