510(k) K946353 ยท LLM Test, Antigen, Nuclear, Epstein-Barr Virus
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY
| Applicant | Mrl Diagnostics, Cypress CA, US |
| Decision | Substantially Equivalent, Jul 21, 1995 |
| Received | Dec 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946353
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.