Cleared Traditional

SYSMEX XN SERIES

K141681 · Sysmex America, Inc. · Hematology
Dec 2014
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K141681 is an FDA 510(k) clearance for the SYSMEX XN SERIES, 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 5, 2014, 165 days after receiving the submission on June 23, 2014. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K141681 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2014
Decision Date December 05, 2014
Days to Decision 165 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