510(k) K080183 ยท DIF Drug Mixture Control Materials
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 25, 2008 |
| Received | Jan 25, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K080183
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.