510(k) K012399 ยท JIT Calibrator, Secondary
MODIFICATION TO ELECSYS FSH II CALSET
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 24, 2001 |
| Received | Jul 27, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012399
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.