DeviceClearance

K913305

Substantially Equivalent

CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER

Applicant
Unipath , Ltd.
Product code
GKZ
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mountain View, CA, 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.