510(k) K900354— TOXO IGG ELISA TEST

Substantially Equivalent

Gull Laboratories, Inc.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1990-01-25
Decision date: 1990-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.