LECTIN-A— 510(k) K820368

Substantially Equivalent

American Dade

FDA 510(k) clearance K820368 for LECTIN-A, Substantially Equivalent on 1982-04-14. Applicant: American Dade.

Clearance details

Applicant: American Dade
Product code: Code KSI
Advisory panel: Hematology
Date received: 1982-02-09
Decision date: 1982-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KSI

product code KSI

Malfunction: 700
Total: 700

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.