510(k) K980650 ยท JHO Electrophoretic Separation, Lipoproteins
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, May 1, 1998 |
| Received | Feb 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980650
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.