VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.— 510(k) K900818

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K900818 for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO., Substantially Equivalent on 1990-04-30. Applicant: Vitek Systems, Inc..

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1990-02-21
Decision date: 1990-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MI, 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.