Cleared Traditional

SYSMEX MODEL XT-4000I

K091313 · Sysmex America, Inc. · Hematology
Mar 2010
Decision
330d
Days
Class 2
Risk

About This 510(k) Submission

K091313 is an FDA 510(k) clearance for the SYSMEX MODEL XT-4000I, 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 March 30, 2010, 330 days after receiving the submission on May 4, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K091313 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2009
Decision Date March 30, 2010
Days to Decision 330 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