510(k) K991459 ยท LJN Antibody Igm, If, Epstein-Barr Virus
COPALIS EBV-M ANTIBODY ASSAY
| Applicant | DiaSorin, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, May 14, 1999 |
| Received | Apr 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991459
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.