510(k) K981946 ยท KTN System, Test, Infectious Mononucleosis
CLEARVIEW IM
| Applicant | Unipath , Ltd., Bedford, GB |
| Decision | Substantially Equivalent, Dec 10, 1998 |
| Received | Jun 3, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981946
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.