510(k) K881247 ยท KTN System, Test, Infectious Mononucleosis
MONO-PHILE
| Applicant | Bio Diagnostic Systems, Inc., Princeton NJ, US |
| Decision | Substantially Equivalent, Apr 7, 1988 |
| Received | Mar 23, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881247
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.