ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM— 510(k) K951495

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K951495 for ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM, Substantially Equivalent on 1995-12-20. Applicant: Bio-Rad Laboratories, Inc..

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1995-03-31
Decision date: 1995-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, 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.