510(k) K121492 ยท LCP Assay, Glycosylated Hemoglobin
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Sep 11, 2012 |
| Received | May 21, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121492
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.