ADENOVIRUS R-GENE US— 510(k) K121942

Name: FDA 510(k) clearance K121942
Creator: U.S. Food and Drug Administration
Published: 2013-02-08

Substantially Equivalent

Argene SA

FDA 510(k) clearance K121942 for ADENOVIRUS R-GENE US, Substantially Equivalent on 2013-02-08. Applicant: Argene SA. Device class: 2.

Clearance details

Applicant: Argene SA
Product code: Code OCC
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2012-07-02
Decision date: 2013-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Varilhes, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

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.