LKB-WALLAC 1230 ARCUS FLUOROMETER— 510(k) K851984

Name: FDA 510(k) clearance K851984
Creator: U.S. Food and Drug Administration
Published: 1985-05-24

Substantially Equivalent

Lkb Instruments, Inc.

FDA 510(k) clearance K851984 for LKB-WALLAC 1230 ARCUS FLUOROMETER, Substantially Equivalent on 1985-05-24. Applicant: Lkb Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Lkb Instruments, Inc.
Product code: Code KHO
Device class: Class 1
Regulation: 21 CFR 862.2560
Advisory panel: Clinical Chemistry
Date received: 1985-05-07
Decision date: 1985-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KHO

product code KHO

Malfunction: 1,339
Total: 1,339

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.