GELSCAN SOFTWARE 2190— 510(k) K834490

Name: FDA 510(k) clearance K834490
Creator: U.S. Food and Drug Administration
Published: 1984-05-01

Substantially Equivalent

Lkb Instruments, Inc.

FDA 510(k) clearance K834490 for GELSCAN SOFTWARE 2190, Substantially Equivalent on 1984-05-01. Applicant: Lkb Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Lkb Instruments, Inc.
Product code: Code JQP
Device class: Class 1
Regulation: 21 CFR 862.2100
Advisory panel: Clinical Chemistry
Date received: 1983-12-06
Decision date: 1984-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

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.