VIDAS TOXO COMPETITION (TXC) ASSAY— 510(k) K931334

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K931334 for VIDAS TOXO COMPETITION (TXC) ASSAY, Substantially Equivalent on 1993-06-21. Applicant: Biomerieux Vitek, Inc..

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1993-03-16
Decision date: 1993-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, 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, 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.