DeviceClearance

K792582

Substantially Equivalent

POLY-LEC SYSTEM

Applicant
Gamma Biologicals, Inc.
Product code
KSI
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KSI

product code KSI
Malfunction
700
Total
700

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.