510(k) K002353 ยท JIS Calibrator, Primary
ELECSYS CA 15-3 CALCHECK
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 10, 2000 |
| Received | Aug 2, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002353
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.