510(k) K861311 ยท CFR Hexokinase, Glucose
GLUCOSE (HEXOKINASE) REAGENT SET
| Applicant | Sterling Diagnostics, Inc., Sterling Heights MI, US |
| Decision | Substantially Equivalent, Apr 24, 1986 |
| Received | Apr 8, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861311
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.