510(k) K080916 ยท JKM Immunochemical, Bence-Jones Protein
CAPILLARYS URINE
| Applicant | Sebia, Norcross GA, US |
| Decision | Substantially Equivalent, Jul 1, 2008 |
| Received | Apr 2, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080916
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.