510(k) K052291 ยท GKA Abnormal Hemoglobin Quantitation
CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
| Applicant | Sebia, Chelsea MI, US |
| Decision | Substantially Equivalent, Jun 27, 2006 |
| Received | Aug 23, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052291
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.