510(k) K954447 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
C-REACTIVE PROTEIN LATEX KIT
| Applicant | Randox Laboratories, Ltd., Crumlin, IE |
| Decision | Substantially Equivalent, Dec 18, 1995 |
| Received | Sep 25, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954447
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.