Cleared Traditional

SYSMEX XE-5000

K071967 · Sysmex America, Inc. · Hematology
Nov 2007
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K071967 is an FDA 510(k) clearance for the SYSMEX XE-5000, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Sysmex America, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 20, 2007, 127 days after receiving the submission on July 16, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K071967 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2007
Decision Date November 20, 2007
Days to Decision 127 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