510(k) K852131 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
BUN(ENDPOINT) REAGENT
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Jun 10, 1985 |
| Received | May 16, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852131
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.