K962343

Substantially Equivalent

TOXO IGG ELISA TEST

Applicant
Gull Laboratories, Inc.
Product code
LGD
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Salt Lake City, UT, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LGD

product code LGD
Malfunction
502
Total
502

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.