revogene— 510(k) K170558

Substantially Equivalent

Genepoc, Inc.

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

Clearance details

Applicant: Genepoc, Inc.
Product code: Code OOI
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 ↗

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.