510(k) K063209 ยท LCP Assay, Glycosylated Hemoglobin
HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
| Applicant | Thermo Electron OY, Vantaa, FI |
| Decision | Substantially Equivalent, Mar 21, 2007 |
| Received | Oct 23, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063209
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.