510(k) K863196 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
BUN (RATE) REAGENT
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Aug 26, 1986 |
| Received | Aug 19, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863196
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.