INNOTRON FLUORIMETER SERIES ONE-10— 510(k) K822942

Name: FDA 510(k) clearance K822942
Creator: U.S. Food and Drug Administration
Published: 1982-12-09

Substantially Equivalent

Innotron of Oregon, Inc.

FDA 510(k) clearance K822942 for INNOTRON FLUORIMETER SERIES ONE-10, Substantially Equivalent on 1982-12-09. Applicant: Innotron of Oregon, Inc.. Device class: 1.

Clearance details

Applicant: Innotron of Oregon, Inc.
Product code: Code KHO
Device class: Class 1
Regulation: 21 CFR 862.2560
Advisory panel: Clinical Chemistry
Date received: 1982-10-04
Decision date: 1982-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.