510(k) K992800 ยท CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Sep 28, 1999 |
| Received | Aug 19, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992800
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.