510(k) K992971 ยท JHO Electrophoretic Separation, Lipoproteins
REP CHOLESTEROL PROFILE KIT
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 18, 1999 |
| Received | Sep 3, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992971
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.