510(k) K182651 ยท PDJ Hemoglobin A1c Test System
HbA1c Advanced
| Applicant | Beckman Coulter Ireland, Inc., O'Callaghan'S Mills, IE |
| Decision | Substantially Equivalent, Jan 16, 2019 |
| Received | Sep 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182651
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.