510(k) K935162 ยท JHO Electrophoretic Separation, Lipoproteins
REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Nov 10, 1994 |
| Received | Oct 29, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935162
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.