510(k) K101456 ยท JIX Calibrator, Multi-Analyte Mixture
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 8, 2010 |
| Received | May 26, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101456
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.