510(k) K812341 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
UREA NITROGEN (BUN)
| Applicant | Pointe Scientific, Inc.,, Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 1, 1981 |
| Received | Aug 18, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812341
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.