Cleared Traditional

Sysmex XN-L Automated Hematology Analyzer

K160538 · Sysmex America, Inc. · Hematology
Dec 2016
Decision
300d
Days
Class 2
Risk

About This 510(k) Submission

K160538 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 December 22, 2016, 300 days after receiving the submission on February 26, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K160538 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2016
Decision Date December 22, 2016
Days to Decision 300 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