Cleared Traditional

SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES

K061150 · Sysmex America, Inc. · Hematology
Jul 2006
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K061150 is an FDA 510(k) clearance for the SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES, 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 July 6, 2006, 72 days after receiving the submission on April 25, 2006. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K061150 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2006
Decision Date July 06, 2006
Days to Decision 72 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