510(k) K884147 ยท DFT Igm, Antigen, Antiserum, Control
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
| Applicant | Orion Diagnostica, Inc., 02101 Espoo, FI |
| Decision | Substantially Equivalent, Oct 27, 1988 |
| Received | Oct 3, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884147
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.