Cleared Traditional

K112605 - SYSMEX XN-SERIES
(FDA 510(k) Clearance)

K112605 · Sysmex America, Inc. · Hematology
Oct 2012
Decision
408d
Days
Class 2
Risk

K112605 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 October 19, 2012, 408 days after receiving the submission on September 7, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K112605 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2011
Decision Date October 19, 2012
Days to Decision 408 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