Cleared Traditional

SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER

K051459 · Sysmex America, Inc. · Hematology
Sep 2005
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K051459 is an FDA 510(k) clearance for the SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER, 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 September 23, 2005, 113 days after receiving the submission on June 2, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K051459 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2005
Decision Date September 23, 2005
Days to Decision 113 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