Cleared Traditional

Alinity h-series System

K220031 · Abbott Laboratories · Hematology
Aug 2023
Decision
576d
Days
Class 2
Risk

About This 510(k) Submission

K220031 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 August 4, 2023, 576 days after receiving the submission on January 5, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K220031 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 2022
Decision Date August 04, 2023
Days to Decision 576 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