Genomadix Cube CYP2C19 System— 510(k) K220026

Substantially Equivalent

Genomadix, Inc.

FDA 510(k) clearance K220026 for Genomadix Cube CYP2C19 System, Substantially Equivalent on 2023-03-21. Applicant: Genomadix, Inc.. Device class: 2.

Clearance details

Applicant: Genomadix, Inc.
Product code: Code NTI
Device class: Class 2
Regulation: 21 CFR 862.3360
Advisory panel: Clinical Toxicology
Date received: 2022-01-05
Decision date: 2023-03-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Kanata (Ottawa), CA

Download summary PDF View on FDA.gov ↗

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