510(k) K120199 ยท LCP Assay, Glycosylated Hemoglobin
GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Oct 12, 2012 |
| Received | Jan 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120199
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.