VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210— 510(k) K993319

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K993319 for VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210, Substantially Equivalent on 2000-05-22. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1999-10-04
Decision date: 2000-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

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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.