CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY— 510(k) K871746

Substantially Equivalent

Mercia Diagnostics , Ltd.

FDA 510(k) clearance K871746 for CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY, Substantially Equivalent on 1987-07-31. Applicant: Mercia Diagnostics , Ltd..

Clearance details

Applicant: Mercia Diagnostics , Ltd.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 1987-05-05
Decision date: 1987-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guildford, Surrey England, GB

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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.