Alinity i Total ß-hCG Reagent Kit, Alinity i System— 510(k) K170317
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K170317 for Alinity i Total ß-hCG Reagent Kit, Alinity i System, Substantially Equivalent on 2017-10-23. Applicant: Abbott Laboratories. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code DHA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abbott Park, IL, US
Recent devices under product code DHA
view all- K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
- K223690 — iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
- K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track
- K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
- K221990 — Access Total ßhCG (5th IS)
More clearances from Abbott Laboratories
view allAdverse events under product code DHA
product code DHA- Malfunction
- 1,242
- Total
- 1,242
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K170317
K-number listed on FDA's recall record- Z-0961-2026 — Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
- Z-0958-2023 — Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
- Z-0666-2019 — Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170317.
Data sourced from openFDA. This site is unofficial and independent of the FDA.