Clinistat Total Bilirubin Reagent Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K892801 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

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. →