510(k) K011226 ยท JIX Calibrator, Multi-Analyte Mixture
CALIBRATOR FOR AUTOMATED SYSTEMS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 25, 2001 |
| Received | Apr 20, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K011226
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.