510(k) K173206 ยท PDJ Hemoglobin A1c Test System
SEKURE HbA1c Assay
| Applicant | Sekisui Diagnostics P.E.I., Inc., Charlottetown,, CA |
| Decision | Substantially Equivalent, Jul 12, 2018 |
| Received | Oct 2, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173206
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.