510(k) K964064 ยท MRR System, Test, Low Density, Lipoprotein
RDI LIPIDIRECT MAGNETIC LDL REAGENT
| Applicant | Reference Diagnostics, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Nov 20, 1996 |
| Received | Oct 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964064
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.