DeviceClearance

K023240

Substantially Equivalent

ST AIA-PACK CA 19-9

Applicant
Tosoh Corp.
Product code
NIG
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Seymour, CT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code NIG

product code NIG
Malfunction
618
Total
618

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.