Cholesterol Calibrator Set

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K910962 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the purpose of the Cholesterol Calibrator Set?

  The Cholesterol Calibrator Set is used in clinical chemistry settings to establish the relationship between an instrument signal and the concentration of cholesterol in a sample, ensuring accurate measurement results.

• What is the regulatory status of this device?

  This device is authorized for use under FDA 510(k) clearance number K910962, which was granted on March 29, 1991.

• In what settings is this calibrator intended to be used?

  The device is intended for use within clinical chemistry environments to support standard laboratory testing procedures.