510(k) K033165 ยท DLJ Calibrators, Drug Specific
PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 14, 2003 |
| Received | Sep 30, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K033165
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.