Cleared Traditional

Alinity h-series System

K243283 · Abbott Laboratories · Hematology
Feb 2025
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K243283 is an FDA 510(k) clearance for the Alinity h-series System, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Abbott Laboratories (Santa Clara, US). The FDA issued a Cleared decision on February 20, 2025, 126 days after receiving the submission on October 17, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K243283 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2024
Decision Date February 20, 2025
Days to Decision 126 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220

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