510(k) K163078 ยท JIT Calibrator, Secondary
DC-UIBC-CAL
| Applicant | Sekisui Diagnostics P.E.I., Inc., Charlottetown,, CA |
| Decision | Substantially Equivalent, Dec 8, 2016 |
| Received | Nov 3, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K163078
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.