510(k) K003411 ยท JIT Calibrator, Secondary
ELECSYS TESTOSTERONE CALSET II
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 1, 2001 |
| Received | Nov 2, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K003411
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.