510(k) K862008 ยท KTN System, Test, Infectious Mononucleosis
MONO-LATEX (TM) SLIDE TEST
| Applicant | Armkel, LLC, Cranbury NJ, US |
| Decision | Substantially Equivalent, Jul 3, 1986 |
| Received | May 27, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862008
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.