510(k) K043095 ยท JIT Calibrator, Secondary
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 23, 2004 |
| Received | Nov 9, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043095
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.