510(k) K000603 ยท JHO Electrophoretic Separation, Lipoproteins
SPIFE CHOLESTEROL PROFILE KIT
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Apr 17, 2000 |
| Received | Feb 23, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000603
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.