510(k) K850567— ABBOTT TOXO-M EIA DIAGNOSTIC KIT

Substantially Equivalent

Abbott Laboratories

Clearance details

Applicant: Abbott Laboratories
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1985-02-12
Decision date: 1985-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, 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.