510(k) K050119 ยท JKM Immunochemical, Bence-Jones Protein
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, May 6, 2005 |
| Received | Jan 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050119
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.