Revogene— 510(k) K220480

Name: FDA 510(k) clearance K220480
Creator: U.S. Food and Drug Administration
Published: 2022-07-11

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K220480 for Revogene, Substantially Equivalent on 2022-07-11. Applicant: Meridian Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code OOI
Device class: Class 2
Regulation: 21 CFR 862.2570
Advisory panel: Clinical Chemistry
Date received: 2022-02-18
Decision date: 2022-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OOI

product code OOI

Malfunction: 2,506
Other: 3
Total: 2,509

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.