510(k) K112550 ยท GKA Abnormal Hemoglobin Quantitation
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, May 25, 2012 |
| Received | Sep 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112550
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.