DeviceClearance

K172604

Substantially Equivalent

XW-100 Automated Hematology Analyzer for CLIA Waived Use

Applicant
Sysmex America, Inc.
Product code
GKZ
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Dual Track
Location
Lincolnshire, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GKZ

product code GKZ
Malfunction
1,205
Total
1,205

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.