Low Potassium Dextran Solution with Tris Diluent— 510(k) K153384

Name: FDA 510(k) clearance K153384
Creator: U.S. Food and Drug Administration
Published: 2016-02-19

Substantially Equivalent

United Therapeutics Corporation

FDA 510(k) clearance K153384 for Low Potassium Dextran Solution with Tris Diluent, Substantially Equivalent on 2016-02-19. Applicant: United Therapeutics Corporation. Device class: 2.

Clearance details

Applicant: United Therapeutics Corporation
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2015-11-23
Decision date: 2016-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

Download summary PDF View on FDA.gov ↗

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