510(k) K033501 ยท JIX Calibrator, Multi-Analyte Mixture
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 20, 2003 |
| Received | Nov 5, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033501
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.