510(k) K884007 ยท KTN System, Test, Infectious Mononucleosis
CARDS(TM) MONO
| Applicant | Pacific Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 18, 1988 |
| Received | Sep 21, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884007
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.