510(k) K950382 ยท JHN Turbidimetric Method, Lipoproteins
APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT
| Applicant | Randox Laboratories, Ltd., Crumlin, Co. Antrim, IE |
| Decision | Substantially Equivalent, Sep 15, 1995 |
| Received | Jan 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950382
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.