510(k) K991362 ยท JBD System, Analysis, Electrophoretic Hemoglobin
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
| Applicant | Morax, Chelsea MI, US |
| Decision | Substantially Equivalent, Jun 21, 1999 |
| Received | Apr 14, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991362
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2006 | Sebia, Inc. HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France Terminated |
JBD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.