GAMMA ARACHIS HYPOGEA LECTIN— 510(k) K792583

Name: FDA 510(k) clearance K792583
Creator: U.S. Food and Drug Administration
Published: 1980-01-16

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.. Device class: 2.

Clearance details

Applicant: Gamma Biologicals, Inc.
Product code: Code KSI
Device class: Class 2
Regulation: 21 CFR 864.9550
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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More clearances from Gamma Biologicals, Inc.

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K864207 — DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO1986-12-03
K861016 — GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS1986-04-18
K832473 — GAMMA SLIDE TEST FOR PREGNANCY1983-08-16
K820647 — GAMMA FETAL BLEED SCREENING TEST1982-05-12
K813342 — GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION1982-03-04

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.