GAMMA ARACHIS HYPOGEA LECTIN— 510(k) K792583

Substantially Equivalent

Gamma Biologicals, Inc.

FDA 510(k) clearance K792583 for GAMMA ARACHIS HYPOGEA LECTIN, Substantially Equivalent on 1980-01-16. Applicant: Gamma Biologicals, Inc..

Clearance details

Applicant: Gamma Biologicals, Inc.
Product code: Code KSI
Advisory panel: Hematology
Date received: 1979-12-14
Decision date: 1980-01-16
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.