Cleared Traditional

XW-100 Automated Hematology Analyzer, XW QC CHECK

K143577 · Sysmex America, Inc. · Hematology
Oct 2015
Decision
299d
Days
Class 2
Risk

About This 510(k) Submission

K143577 is an FDA 510(k) clearance for the XW-100 Automated Hematology Analyzer, XW QC CHECK, 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 12, 2015, 299 days after receiving the submission on December 17, 2014. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K143577 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2014
Decision Date October 12, 2015
Days to Decision 299 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