510(k) K170317 · DHA System, Test, Human Chorionic Gonadotropin
Alinity i Total ß-hCG Reagent Kit, Alinity i System
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Oct 23, 2017 |
| Received | Feb 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170317
| 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 |
| Jan 17, 2023 | Abbott Laboratories Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels Open, Classified |
DHA | None listed |
| Nov 21, 2018 | Abbott Ireland Diagnostics Division Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 Terminated |
DHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.