510(k) K872252— MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT

Substantially Equivalent

Labsystems, Inc.

Clearance details

Applicant
Labsystems, Inc.
Product code
Code LGD
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Morton Grove, IL, US
Download summary PDFView 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.