510(k) K063498 ยท OBZ Alpha-1-Antitrypsin Kit, Qualitative Phenotype
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
| Applicant | Sebia, Great Neck NY, US |
| Decision | Substantially Equivalent, Jun 11, 2007 |
| Received | Nov 20, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063498
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.