Directdraw Superserum-Mini

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K935081 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Hemochron(R) Kact

  Class II

  FDA 510(k) K913861 Active Cleared 18 Oct 1991

• Hemochron Jr Generation II, Hemochron Jr Signature

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  FDA 510(k) K974799 Active Cleared 7 Jul 1998

• Hemochron Citrate Aptt

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  FDA 510(k) K972831 Active Cleared 20 Nov 1997

• Protime Microcoagulation System

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  FDA 510(k) K951072 Active Cleared 27 Oct 1995

• Tenderfoot

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  FDA 510(k) K883968 Active Cleared 1 Dec 1988

• Prothrombin Time (Pt) by Hemochron, Modification

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  FDA 510(k) K911995 Active Cleared 17 Jul 1991

See all devices from International Technidyne Corp. →

• What is the Directdraw Superserum-Mini used for?

  The Directdraw Superserum-Mini is a chemistry device designed specifically for blood collection and serum separation procedures in clinical settings.

• Is the Directdraw Superserum-Mini reusable or single-use?

  This device is supplied as a single-use product and should not be reused to ensure patient safety and maintain device integrity.

• What are the storage requirements for the Directdraw Superserum-Mini?

  The Directdraw Superserum-Mini is stored at room temperature, making it convenient for clinical environments without special refrigeration needs.

• What regulatory clearance has the Directdraw Superserum-Mini received?

  The device has received FDA 510(k) clearance with number K935081 on January 11, 1994, and is classified under product code JKA.