510(k) K864207 ยท KTN System, Test, Infectious Mononucleosis
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO
| Applicant | Gamma Biologicals, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Dec 3, 1986 |
| Received | Oct 27, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864207
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.