510(k) K982236 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Aug 5, 1998 |
| Received | Jun 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982236
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.