510(k) K140829 ยท LCP Assay, Glycosylated Hemoglobin
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jul 14, 2014 |
| Received | Apr 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140829
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.