Low Potassium Dextran Solution with Tris Diluent
K-Number: K153384 · 2016-02-19
ApplicantUnited Therapeutics Corporation
Decision Date2016-02-19
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Low Potassium Dextran Solution with Tris Diluent is a medical device manufactured by United Therapeutics Corporation. It received FDA 510(k) clearance on 2016-02-19 under approval number K153384. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Low Potassium Dextran Solution with Tris Diluent?
Low Potassium Dextran Solution with Tris Diluent is a medical device that received FDA 510(k) clearance on 2016-02-19. It is manufactured by United Therapeutics Corporation. The 510(k) number is K153384.
When was Low Potassium Dextran Solution with Tris Diluent approved by the FDA?
Low Potassium Dextran Solution with Tris Diluent received FDA 510(k) clearance on 2016-02-19, under approval number K153384.
What company makes Low Potassium Dextran Solution with Tris Diluent?
Low Potassium Dextran Solution with Tris Diluent is manufactured by United Therapeutics Corporation.
What is the FDA product code for Low Potassium Dextran Solution with Tris Diluent?
The FDA product code for Low Potassium Dextran Solution with Tris Diluent is KDN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.