510(k) K061069 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jul 6, 2006 |
| Received | Apr 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061069
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.