510(k) K082227 ยท GKA Abnormal Hemoglobin Quantitation
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Mar 26, 2009 |
| Received | Aug 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082227
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.