510(k) K103221 ยท JIT Calibrator, Secondary
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 23, 2010 |
| Received | Nov 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103221
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.