510(k) K894378 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
UREA NITROGEN TEST (BUN) ITEM #65408
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Aug 31, 1989 |
| Received | Jul 17, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894378
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.