Tri-Tech Inc. Custom Blood Alcohol

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

510(k) Number

K922342 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SEKD

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See all devices from Tri-Tech, Inc. →

• What is the Tri-Tech Custom Blood Alcohol device used for?

  The Tri-Tech Custom Blood Alcohol is a blood specimen collection device designed for medical purposes to collect and handle blood specimens and separate serum from nonserum components prior to further testing in clinical chemistry applications.

• How is the Tri-Tech Custom Blood Alcohol device supplied?

  The device is supplied as part of a kit with drugs and is regulated under product code JKA with FDA 510(k) clearance number K922342, granted on 1993-08-27.

• Is the Tri-Tech Custom Blood Alcohol device single-use or reusable?

  The device description does not specify whether it is single-use or reusable. For proper usage instructions, please refer to the manufacturer's documentation or contact Tri-Tech, Inc. directly.

• What is the regulatory status of the Tri-Tech Custom Blood Alcohol device?

  The device has FDA 510(k) clearance number K922342, granted on 1993-08-27, and is regulated under product code JKA. It is manufactured by Tri-Tech, Inc. in Durham, NC.