Bio Trol-T Triolein Solutions

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K770072 ↗

FDA Product Code

JIS

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Boehringer Mannheim Corp. →

• What is the Bio Trol-T Triolein Solutions used for?

  Bio Trol-T Triolein Solutions is a primary calibrator device used in clinical chemistry laboratories to provide reference values for triolein measurements in clinical testing procedures.

• How is the Bio Trol-T Triolein Solutions supplied?

  The device is supplied as a solution and is intended specifically for laboratory use in clinical chemistry testing procedures.

• What is the regulatory classification of the Bio Trol-T Triolein Solutions?

  The device is regulated under FDA 510(k) clearance with product code JIS and is classified as a Class II medical device, having been cleared on January 26, 1977.

• Is the Bio Trol-T Triolein Solutions reusable or single-use?

  The device description does not specify whether it is reusable or single-use, only that it is supplied as a solution for laboratory use in clinical chemistry testing.