510(k) K771397 ยท KTN System, Test, Infectious Mononucleosis
MONOSTICON TEST
| Applicant | Organon, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 22, 1977 |
| Received | Jul 29, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K771397
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.