510(k) K010652 ยท JIX Calibrator, Multi-Analyte Mixture
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 30, 2001 |
| Received | Mar 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010652
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.