510(k) K891542 ยท LLM Test, Antigen, Nuclear, Epstein-Barr Virus
EBNA-CHECK(TM) TEST KIT
| Applicant | Diagnostic Technology, Inc., Hauppauge NY, US |
| Decision | Substantially Equivalent, Jun 20, 1989 |
| Received | Mar 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891542
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.