510(k) K972231 ยท KTN System, Test, Infectious Mononucleosis
OSOM MONO TEST 143
| Applicant | Wyntek Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 26, 1997 |
| Received | Jun 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972231
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.