510(k) K170316 ยท CFR Hexokinase, Glucose
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Oct 19, 2017 |
| Received | Feb 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170316
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | Abbott Laboratories Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 Open, Classified |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.