LECTIN H— 510(k) K813413

Name: FDA 510(k) clearance K813413
Creator: U.S. Food and Drug Administration
Published: 1982-03-04

Substantially Equivalent

American Dade

FDA 510(k) clearance K813413 for LECTIN H, Substantially Equivalent on 1982-03-04. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code KSI
Device class: Class 2
Regulation: 21 CFR 864.9550
Advisory panel: Hematology
Date received: 1981-12-07
Decision date: 1982-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KSI

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K820368 — LECTIN-A1982-04-14
K792582 — POLY-LEC SYSTEM1980-01-16
K792583 — GAMMA ARACHIS HYPOGEA LECTIN1980-01-16

More clearances from American Dade

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K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

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.