510(k) K984574 ยท CFR Hexokinase, Glucose
INFINITY GLUCOSE REAGENT
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Feb 11, 1999 |
| Received | Dec 23, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984574
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.