510(k) K001403 ยท CFR Hexokinase, Glucose
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Aug 10, 2000 |
| Received | May 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001403
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.