Cleared Dual Track

Sysmex XW-100 Automated Hematology Analyzer

K210346 · Sysmex America, Inc. · Hematology
Nov 2022
Decision
638d
Days
Class 2
Risk

About This 510(k) Submission

K210346 is an FDA 510(k) clearance for the Sysmex XW-100 Automated Hematology Analyzer, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on November 8, 2022, 638 days after receiving the submission on February 8, 2021. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K210346 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2021
Decision Date November 08, 2022
Days to Decision 638 days
Submission Type Dual Track
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