510(k) K003941 ยท JIS Calibrator, Primary
ELECSYS HCG STAT CLASET II
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 25, 2001 |
| Received | Dec 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003941
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.