510(k) K973123 ยท LSE Epstein-Barr Virus, Other
EA-D IGG ELISA TEST SYSTEM
| Applicant | Clark Laboratories, Inc., Frederick MD, US |
| Decision | Substantially Equivalent, Mar 26, 1998 |
| Received | Aug 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973123
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.