510(k) K884987 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jan 13, 1989 |
| Received | Dec 1, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884987
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.