510(k) K872541 ยท LJN Antibody Igm, If, Epstein-Barr Virus
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, May 13, 1988 |
| Received | Jun 29, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K872541
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.