Cleared Traditional

Sysmex XN-L Automated Hematology Analyzer

K182389 · Sysmex America, Inc. · Hematology
Jan 2019
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K182389 is an FDA 510(k) clearance for the Sysmex XN-L 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 January 25, 2019, 143 days after receiving the submission on September 4, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K182389 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2018
Decision Date January 25, 2019
Days to Decision 143 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