FDA 510(k)

Low Potassium Dextran Solution with Tris Diluent

K-번호: K153384 · 2016-02-19

결정일2016-02-19

제품 코드KDN

자문 위원회GU

결정Substantially Equivalent

기기 요약

Low Potassium Dextran Solution with Tris Diluent is the device name listed in this FDA 510(k) record. The listed applicant is United Therapeutics Corporation. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K153384. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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. The listed applicant is United Therapeutics Corporation. The 510(k) number is K153384.

When did Low Potassium Dextran Solution with Tris Diluent receive FDA 510(k) clearance?

Low Potassium Dextran Solution with Tris Diluent received FDA 510(k) clearance on 2016-02-19, under 510(k) number K153384.

Who is the listed applicant for Low Potassium Dextran Solution with Tris Diluent?

The FDA 510(k) record lists United Therapeutics Corporation as the applicant. This does not by itself establish the device manufacturer.

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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Low Potassium Dextran Solution with Tris Diluent

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관련 임상시험

관련 기기 (코드: KDN)

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