510(k) K980598 ยท LLM Test, Antigen, Nuclear, Epstein-Barr Virus
EBNA-1 IGM ELISA TEST SYSTEM
| Applicant | Clark Laboratories, Inc., Frederick MD, US |
| Decision | Substantially Equivalent, May 1, 1998 |
| Received | Feb 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980598
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.