510(k) K013466 ยท JHO Electrophoretic Separation, Lipoproteins
SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Dec 21, 2001 |
| Received | Oct 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013466
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.