510(k) K911569 ยท LLM Test, Antigen, Nuclear, Epstein-Barr Virus
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Jun 10, 1991 |
| Received | Apr 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911569
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.