Mucosal Integrity Conductivity (MI) Test System— 510(k) DEN180067

Name: FDA 510(k) clearance DEN180067
Creator: U.S. Food and Drug Administration
Published: 2019-12-23

Unknown

Diversatek Healthcare, Inc.

FDA 510(k) clearance DEN180067 for Mucosal Integrity Conductivity (MI) Test System, Unknown on 2019-12-23. Applicant: Diversatek Healthcare, Inc.. Device class: 2.

Clearance details

Applicant: Diversatek Healthcare, Inc.
Product code: Code QIS
Device class: Class 2
Regulation: 21 CFR 876.1450
Advisory panel: Gastroenterology, Urology
Date received: 2018-12-17
Decision date: 2019-12-23
Decision: Unknown
Clearance type: Direct
Location: Highlands Ranch, CO, US

View on FDA.gov ↗

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