Cleared Dual Track

XW-100 Automated Hematology Analyzer for CLIA Waived Use

K172604 · Sysmex America, Inc. · Hematology
Nov 2017
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K172604 is an FDA 510(k) clearance for the XW-100 Automated Hematology Analyzer for CLIA Waived Use, 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 November 6, 2017, 68 days after receiving the submission on August 30, 2017. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K172604 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2017
Decision Date November 06, 2017
Days to Decision 68 days
Submission Type Dual Track
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