510(k) K024162 ยท CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Feb 19, 2003 |
| Received | Dec 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024162
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.