510(k) K870571 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Mar 4, 1987 |
| Received | Feb 10, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870571
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.