510(k) K821386 ยท KTN System, Test, Infectious Mononucleosis
SERO/TEX MONO TEST
| Applicant | Texas Immunology, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 2, 1982 |
| Received | May 10, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821386
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.