510(k) K895891 ยท KTN System, Test, Infectious Mononucleosis
DETECTADOT SYSTEM 2000 HETEROPHILE TEST
| Applicant | Gull Laboratories, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 31, 1989 |
| Received | Oct 5, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895891
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.