Alinity h-series System— 510(k) K220031
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K220031 for Alinity h-series System, Substantially Equivalent on 2023-08-04. Applicant: Abbott Laboratories. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code GKZ
view allMore clearances from Abbott Laboratories
view allAdverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
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 K220031
K-number listed on FDA's recall record- Z-0489-2026 — Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
- Z-2681-2024 — Alinity hq Analyzer, REF: 09P68-01
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220031.
Data sourced from openFDA. This site is unofficial and independent of the FDA.