510(k) K962914 ยท JHO Electrophoretic Separation, Lipoproteins
REP 3 QUTO-FLUR CHOLESTEROL-30
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Jan 13, 1997 |
| Received | Jul 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962914
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.