510(k) K922726 ยท KTN System, Test, Infectious Mononucleosis
TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL
| Applicant | Simplicity Diagnostics, Inc., Hatboro PA, US |
| Decision | Substantially Equivalent, Oct 5, 1992 |
| Received | Jun 5, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922726
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.