510(k) K052982 ยท JIT Calibrator, Secondary
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 28, 2005 |
| Received | Oct 24, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052982
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.