Infinity Cholesterol Reagent (Procedure No. 401)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K980667 ↗

FDA Product Code

CHH

Device Class

Class I

Regulation

21 CFR Part 862.1175

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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See all devices from Sigma Diagnostics, Inc. →