510(k) K860135 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
EASY-TEST UREA (BUN) REAGENT
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Feb 21, 1986 |
| Received | Jan 14, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860135
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.