510(k) K883540 ยท KTN System, Test, Infectious Mononucleosis
OXOID INFECTIOUS MONONUCLEOSIS KIT
| Applicant | Unipath , Ltd., Bedford Mk41 Oqg, GB |
| Decision | Substantially Equivalent, Oct 19, 1988 |
| Received | Aug 18, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883540
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2006 | Remel, Inc. Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England Terminated |
KTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.