510(k) K861452 ยท KTN System, Test, Infectious Mononucleosis
MONOSTAR SYSTEM: IM LATEX TEST
| Applicant | U.S. Health Resources Corp., Miami FL, US |
| Decision | Substantially Equivalent, May 13, 1986 |
| Received | Apr 18, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861452
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.