Clinistat Hdl Cholesterol Reagent Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K895139 ↗

FDA Product Code

LBS

Device Class

Class I

Regulation

21 CFR Part 862.1475

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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See all devices from Heraeus Kulzer, Inc. →