510(k) K895652 ยท LSE Epstein-Barr Virus, Other
EBV-EA IFA KIT
| Applicant | Organon Teknika Treyburn, Durham NC, US |
| Decision | Substantially Equivalent, Dec 18, 1989 |
| Received | Sep 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895652
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.