revogene— 510(k) K170558

Name: FDA 510(k) clearance K170558
Creator: U.S. Food and Drug Administration
Published: 2017-05-25

Substantially Equivalent

Genepoc, Inc.

FDA 510(k) clearance K170558 for revogene, Substantially Equivalent on 2017-05-25. Applicant: Genepoc, Inc.. Device class: 2.

Clearance details

Applicant: Genepoc, Inc.
Product code: Code OOI
Device class: Class 2
Regulation: 21 CFR 862.2570
Advisory panel: Clinical Chemistry
Date received: 2017-02-24
Decision date: 2017-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code OOI

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K243922 — Revogene2025-03-20
K222779 — Revogene2023-01-26
K220480 — Revogene2022-07-11
K161495 — ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)2016-06-30
K160517 — ARIES System2016-04-12

More clearances from Genepoc, Inc.

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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 →

Recalls naming K170558

K-number listed on FDA's recall record

Z-1479-2022 — Revogene, Catalog no. 610210. IVD test instrumentClass II·Ongoing·Meridian Bioscience Inc·20220622
Z-0836-2022 — Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840Class II·Ongoing·Meridian Bioscience Inc·20220215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170558.

Data sourced from openFDA. This site is unofficial and independent of the FDA.