510(k) K091283 ยท GKA Abnormal Hemoglobin Quantitation
CAPILLARYS NEONAT HB (PN 2006)
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Feb 22, 2010 |
| Received | May 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091283
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.