510(k) K042459 ยท LCP Assay, Glycosylated Hemoglobin
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Nov 17, 2004 |
| Received | Sep 10, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042459
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.