510(k) K934533 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
BUN-300/BUN-500 UREA NITROGEN REAGENT
| Applicant | Horizon Diagnostics, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Nov 26, 1993 |
| Received | Sep 17, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934533
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.